On September 22, 2022 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared a $0.40 fourth-quarter 2022 dividend on the company’s common stock, payable December 5, 2022, to holders of the Common Stock of record at the close of business on November 4, 2022 (Press release, Pfizer, SEP 22, 2022, View Source [SID1234621353]). The fourth-quarter 2022 cash dividend will be the 336th consecutive quarterly dividend paid by Pfizer.

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On September 22, 2022 Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, reported financial results for its fiscal fourth quarter and fiscal year ended June 30, 2022 (Press release, Palatin Technologies, SEP 22, 2022, View Source [SID1234621352]).

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"We are excited to have two novel melanocortin receptor peptides with differentiating product profiles progressing in clinical trials – a Phase 3 pivotal study of PL9643 in patients with dry eye disease, and a Phase 2 clinical study of oral PL8177 in patients with ulcerative colitis," stated Carl Spana, Ph.D., President and CEO of Palatin. "Topline results from the Phase 3 study of PL9643 is currently expected in the second quarter calendar of 2023, and the interim analysis and topline results from the Phase 2 study of PL8177 currently expected in the first half of 2023."

Dr. Spana further commented, "Vyleesi sales continue to grow, with our June 30, 2022, quarter showing significant increases across all value metrics, including gross product sales, net product revenue, prescriptions dispensed, refill rates, and commercial insurance reimbursement, compared to the prior quarter and comparable quarter last year."

Financial Highlights for the Fourth Quarter Ended June 30, 2022
Net loss for the quarter ended June 30, 2022, was $12.8 million, or $(1.34) per common share, compared to a net loss of $13.9 million, or $(1.47) per common share, for the same period in 2021.
As of June 30, 2022, the Company had cash and cash equivalents of $29.9 million, compared to $37.7 million as of March 31, 2022 and $60.1 million as of June 30, 2021.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Gross product sales increased 79%, net product revenue increased 257% and prescriptions dispensed increased 49%, over the prior quarter.
Business Highlights and Recent Updates
Anti-Inflammatory / Autoimmune Programs
PL9643 melanocortin agonist for the treatment of dry eye disease (DED)
Positive interim analysis in ongoing Pivotal Phase 3 clinical study in patients with DED.
The independent data monitoring committee (DMC) performed their assessment on the first 120 patients to complete the study and based on their recommendation, Palatin plans to enroll up to an additional 230 patients in the study for a final sample size of 350 patients.
No safety concerns were identified by the DMC.
Topline data readout expected in the second quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT04268069.
PL8177 oral melanocortin agonist for the treatment of ulcerative colitis (UC):
Initiated patient recruitment in a Phase 2 oral formulation study of PL8177 in patients with UC.
Interim assessment is currently expected to occur in the first quarter of calendar year 2023.
Topline data readout is currently expected in the second quarter of calendar year 2023.
Additional trial information, including inclusion and exclusion criteria, can be found at View Source via the identifier NCT05466890.
Vyleesi (bremelanotide injection) / Hypoactive Sexual Desire Disorder (HSDD): Goal of the Vyleesi program is to demonstrate commercial product value in the marketplace with an objective of re-licensing the U.S. rights to a committed women’s healthcare company.
For the fiscal fourth quarter ended June 30, 2022:
Gross product sales increased 79% over the prior quarter, increased 91% over the comparable quarter in 2021.
Net product revenue increased 257% over the prior quarter, increased 857% over the comparable quarter in 2021.
Total prescriptions dispensed increased 49% over the prior quarter, increased 54% compared to the comparable quarter in 2021.
Refill rates, commercial insurance reimbursement, and net revenue per prescription dispensed, increased over the prior quarter and comparable quarter in 2021.
Patients and healthcare providers can learn more about HSDD and Vyleesi at www.vyleesi.com and www.vyleesipro.com
Other:
Redeemable Convertible Preferred Stock: On May 11, 2022, Palatin entered into a securities purchase agreement with institutional investors, selling and issuing 8,100,000 shares of Series B Redeemable Convertible Preferred Stock ("Series B Preferred Stock") and 900,000 shares of Series C Redeemable Convertible Preferred Stock ("Series C Preferred Stock"). Each share of Series B Preferred Stock and Series C Preferred Stock had a purchase price of $1.67 and is convertible into Palatin common stock at an initial conversion price of $11.25 per share. The investors in the Series B Preferred Stock and Series C Preferred Stock also received warrants to purchase up to 66,666 shares of common stock at an exercise price of $12.50 per share, which expire 48 months following issuance. Total gross proceeds from the offering, before deducting offering expenses, is $15.0 million which was deposited in, and is being held in, an escrow account as of June 30, 2022, pending the investors’ election to redeem the shares for cash or in notes, or convert the shares to common stock. The escrowed proceeds have been presented as a deduction to Series B and C Redeemable Convertible Preferred Stock on the Company’s consolidated balance sheet at June 30, 2022.

To the extent any shares of Series B Preferred Stock or Series C Preferred Stock are converted to common shares or redeemed for debt, the Company will use such net proceeds from this offering for working capital and general corporate purposes. Additional information regarding the securities described above and the terms of the offering are included in Palatin’s fiscal year ended June 30, 2022 10-K filing with the United States Securities and Exchange Commission.

Reverse Stock Split: At Palatin’s Annual Meeting of Stockholders held on June 24, 2022, the Company’s stockholders approved the amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock. The Board of Directors approved the implementation of a 1-for-25 reverse stock split effective as of 5:00 p.m. Eastern Time on August 30, 2022. The reverse stock split reduced the number of shares of Palatin’s common stock outstanding from approximately 231,774,000 shares to approximately 9,271,000 shares but did not change the authorized number of shares of Common Stock, which remain at 300,000,000 shares of Common Stock. The Company’s common stock continues to trade on the NYSE American Stock Market under the symbol "PTN."
Fourth Quarter and Fiscal Year Ended June 30, 2022 Financial Results
All share and per share amounts are presented on a post-reverse-split basis, giving effect to the 1- for-25 reverse stock split.

Revenue
Total revenue consists of gross product sales of Vyleesi, net of allowances and accruals, and license and contract revenue.

Vyleesi gross product sales to pharmacy distributors for the quarter ended June 30, 2022, were $2.3 million, with net product revenue of $770,738, compared to gross product sales of $1.2 million, with net product revenue of $80,504, for the comparable quarter in 2021. Gross product sales increased 91% and net product revenue increased 857% over the comparable quarter in 2021.

Vyleesi gross product sales to pharmacy distributors for the fiscal year ended June 30, 2022, were $5.8 million, with net product revenue of $1.2 million, compared to gross product sales of $4.7 million, with negative net product revenue of $283,286, for the fiscal year ended June 30, 2021. Gross product sales increased 23% and net product revenue increased 530% over the fiscal year ended June 30, 2021.

Palatin recognized $250,000 in license and contract revenue for the fiscal year ended June 30, 2022, related to our license agreement with Fosun, compared to $94,689 for the quarter and fiscal year ended June 30, 2021, related to our license agreement with Kwangdong.

Operating Expenses
Total operating expenses were $13.9 million for the quarters ended June 30, 2022 and 2021.

Total operating expenses for the fiscal year ended June 30, 2022, were $38.1 million, compared to $33.2 million for the fiscal year ended June 30, 2021.

The increase in operating expenses was the result of increased research and development expenses primarily related to our ongoing pivotal Phase 3 clinical trial of PL9643, offset by decreased commercial expenses related to Vyleesi.

Other Income / (Expenses)
Total other income, net, consist mainly of unrealized foreign currency transaction gains and losses, which consisted of gains of $325,868 and $389,868, respectively, for the quarter and fiscal year ended June 30, 2022, compared to losses of $221,274 and $212,526, respectively, for the quarter and fiscal year ended June 30, 2021.

Cash Flows
Palatin’s net cash used in operations for the quarter and fiscal year ended June 30, 2022, was $7.7 million and $29.9 million, respectively, compared to net cash used in operations of $8.5 million and $22.6 million, respectively, for the same periods in 2021. The increase in net cash used in operations is mainly due to cash received in fiscal year ended June 30, 2021 related to our Termination Agreement with AMAG Pharmaceuticals offset by a one-time negotiated payment of approximately $7.0 million in the quarter ended December 31, 2020 related to inventory purchase commitments of Vyleesi and by increased operating expenses in fiscal year ended June 30, 2022.

Net Loss
Palatin’s net loss for the quarter and fiscal year ended June 30, 2022, was $12.8 million and $36.2 million, or $(1.34) and $(3.79) per basic and diluted common share, respectively, compared to a net loss of $13.9 million and $33.6 million, or $(1.47) and $(3.55) per basic and diluted common share, respectively, for the same periods in 2021.

The decrease in net loss for the quarter ended June 30, 2022 over the quarter ended June 30, 2021, was mainly due to the increase of net product revenue of Vyleesi. The increase in net loss for the fiscal year ended June 30, 2022 over the fiscal year ended June 30, 2021, was mainly due to increased operating expenses offset by increased Vyleesi total revenues.

Cash Position
As of June 30, 2022, Palatin’s cash and cash equivalents were $29.9 million with $1.8 million of accounts receivable, compared to cash and cash equivalents of $37.7 million with $0.8 million of accounts receivable as of March 31, 2022, and $60.1 million of cash and cash equivalents with $1.6 million of accounts receivable as of June 30, 2021.

The $29.9 million of cash and cash equivalents at June 30, 2022, does not include the $15 Million Private Placement of Redeemable Convertible Preferred Stock. These funds are being held in an escrow account, pending the investors’ election to redeem the shares for cash or in notes, or convert the shares to common stock.

Palatin’s audited financial statements for the year ended June 30, 2022, to be included in the Annual Report on Form 10-K include an audit report from its independent registered public accounting firm, KPMG LLP, that contains a going concern explanatory paragraph.

Conference Call / Webcast
Palatin will host a conference call and audio webcast on September 22, 2022 at 11:00 a.m. Eastern Time to discuss the results of operations in greater detail and provide an update on corporate developments. Individuals interested in listening to the conference call live can dial 1-800-458- 4121 (US/Canada) or 1-313-209-6672 (International), conference ID 8655999. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin’s website at View Source A telephone and audio webcast replay will be available one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (US/Canada) or 1- 719-457-0820 (International), passcode 8655999. The webcast and telephone replay will be available through September 29, 2022.

About Melanocortin Receptor Agonists and Inflammation
The melanocortin receptor ("MCr") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1r through MC5r. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.

Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.

On September 22, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported that a new study in JAMA Network Open, underscoring the clinical utility of the American Society of Breast Surgeons (ASBrS) guidelines recommending universal genetic testing for patients with breast cancer, and showing universal testing improves patient outcomes (Press release, Invitae, SEP 22, 2022, View Source [SID1234621351]). Building on a previous study reported in the Journal of Clinical Oncology, the current study is the first clinical outcomes study of a cohort of unselected patients with breast cancer who underwent universal germline genetic testing. Our data show that genetic information aids patients and their physicians in implementing effective precision treatments and personalized management for their cancer.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

The data confirm the clinical utility of universal germline testing for all patients regardless of cancer type, age, stage or family history as cited in landmark studies published in JAMA Oncology and Clinical Gastroenterology and Hepatology by Invitae and Mayo Clinic.

"This study and others clearly demonstrate the reason universal genetic testing for patients with breast cancer is the current standard of care in clinical practice," said Pat Whitworth, MD, lead author, breast surgical oncologist and director of the Nashville Breast Center. "It is essential for practices to systematically implement universal testing to improve patient care and outcomes. Even more important, this is the only way we find the family members who carry the gene and need prevention. Other guidelines miss half of these unaffected carriers."

In the study, clinicians were asked to assess changes to clinical management as a result of germline genetic testing results for 952 patients. Clinical recommendations were changed for 68% of patients who did not meet the criteria for testing according to previous non-universal guidelines, but were found to have pathogenic variants in cancer predisposition genes. For those with pathogenic variants that did fall within criteria according to previous guidelines, genetic testing impacted management with one or more changes to recommendations reported for 84% of patients.

Clinicians considered testing beneficial for two-thirds of patients with pathogenic variants (e.g. gene-based therapy) and for one-third of patients with either negative results or variants of uncertain significance (e.g. de-escalation of surgical intervention).

ASBrS recommended universal germline genetic testing has the potential to impact millions, as breast cancer is the most frequently diagnosed cancer in women, affecting >7 million worldwide with more than 2 million new cases expected to be diagnosed each year according to the American Cancer Society. Approximately 1 in 8 women (13%) will be diagnosed with invasive breast cancer in their lifetime and 1 in 39 women (3%) will die from breast cancer. Prior to the ASBrS guidelines, only about 25% of patients with breast cancer in the U.S. were getting genetic testing.

"The medical community’s understanding of genetics and cancer, and the underlying evidence, has evolved to make universal genetic testing the standard of care for breast cancer," said Peter Beitsch, MD, surgical oncologist, former president of the ASBrS and co-PI of the iGAP registry at Invitae. "This will not only benefit patients but also entire families – both male and female relatives – since pathogenic variants associated with breast cancer can lead to many different cancers including prostate cancer."

The ASBrS established guidelines recommending germline genetic testing for all patients currently or previously diagnosed with breast cancer in 2019 (Consensus Guidelines on Genetic Testing for Hereditary Breast Cancer from the American Society of Breast Surgeons), catalyzed and supported by our studies in the Journal of Clinical Oncology and Cancers. "The sooner we systematically implement universal genetic testing for patients with breast cancer, the sooner we’ll achieve President Biden’s Cancer Moonshot 2.0 objectives of reducing cancer mortality and improving the lives of patients with cancer and their families," Ed Esplin, MD, PhD, FACMG, FACP, clinical geneticist at Invitae and senior author of the study.

Restrictive guidelines can lead to disparities in cancer care. Offering germline genetic testing to all cancer patients at diagnosis, consistent with the recent expert consensus in JCO Precision Oncology, may help reduce inequities in cancer care by expanding access for all patients to precision therapy or clinical treatment trials.

On September 22, 2022 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss overall survival (OS) data from the ENGOT-OV16/NOVA phase III clinical trial (Press release, GlaxoSmithKline, SEP 22, 2022, View Source [SID1234621349]). NOVA is a randomised, double-blind, placebo-controlled phase III trial of Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor for the maintenance treatment of women with platinum-sensitive recurrent ovarian cancer.

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The phase III NOVA trial met the primary endpoint of progression-free survival (PFS) in both the gBRCAm and non-gBRCAm cohorts, demonstrating a statistically significant and clinically meaningful treatment effect of Zejula in this patient population, regardless of biomarker status. These PFS results served as the primary basis for the US FDA approval for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Overall survival was a secondary endpoint. Updated final overall survival data was recently shared with the FDA.

Hesham Abdullah, SVP, Global Head of Oncology Development, GSK said: "We believe PARP inhibitors, including Zejula, are important options for the maintenance treatment of patients with recurrent ovarian cancer, across all biomarker subgroups, who are in complete or partial response to platinum-based chemotherapy. We look forward to continuing our ongoing discussions with the FDA."

The ODAC meeting is scheduled for 22 November 2022. This is not related to the niraparib indication in the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

About ovarian cancer

Ovarian cancer is the eighth most common cancer in women worldwide. [1] Despite high response rates to platinum-based chemotherapy in the front-line setting, approximately 85% of patients will experience disease recurrence.[2] Once the disease recurs, it is rarely curable, with decreasing time intervals to each subsequent recurrence.

About Zejula (niraparib)

Zejula is an oral, once-daily PARP inhibitor currently being evaluated in multiple pivotal trials. GSK is building a robust clinical development programme by assessing activity across multiple tumour types and evaluating several potential combinations of Zejula with other therapeutics. The ongoing development programme includes several combination studies.

ZEJULA is indicated:

for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy
Important Safety Information for ZEJULA

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), including some fatal cases, was reported in 15 patients (0.8%) out of 1785 patients treated with ZEJULA monotherapy in clinical trials. The duration of therapy in patients who developed secondary MDS/cancer therapy-related AML varied from 0.5 months to 4.9 years. These patients had received prior chemotherapy with platinum agents and/or other DNA-damaging agents including radiotherapy. Discontinue ZEJULA if MDS/AML is confirmed.

Hematologic adverse reactions (thrombocytopenia, anemia, neutropenia, and/or pancytopenia) have been reported in patients receiving ZEJULA. The overall incidence of Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 39%, 31%, and 21% of patients receiving ZEJULA in PRIMA and 29%, 25%, and 20% of patients receiving ZEJULA in NOVA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 4%, 2%, and 2% of patients in PRIMA and 3%, 1%, and 2% of patients in NOVA. In patients who were administered a starting dose of ZEJULA based on baseline weight or platelet count in PRIMA, Grade ≥3 thrombocytopenia, anemia, and neutropenia were reported, respectively, in 22%, 23%, and 15% of patients receiving ZEJULA. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 3%, and 2% of patients. Do not start ZEJULA until patients have recovered from hematological toxicity caused by prior chemotherapy (≤Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter. If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA, and refer the patient to a hematologist for further investigations.

Hypertension and hypertensive crisis have been reported in patients receiving ZEJULA. Grade 3-4 hypertension occurred in 6% of patients receiving ZEJULA vs 1% of patients receiving placebo in PRIMA, with no reported discontinuations. Grade 3-4 hypertension occurred in 9% of patients receiving ZEJULA vs 2% of patients receiving placebo in NOVA, with discontinuation occurring in <1% of patients. Monitor blood pressure and heart rate at least weekly for the first two months, then monthly for the first year, and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of the ZEJULA dose if necessary.

Posterior reversible encephalopathy syndrome (PRES) occurred in 0.1% of 2,165 patients treated with ZEJULA in clinical trials and has also been described in postmarketing reports. Monitor all patients for signs and symptoms of PRES, which include seizure, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension. Diagnosis requires confirmation by brain imaging. If suspected, promptly discontinue ZEJULA and administer appropriate treatment. The safety of reinitiating ZEJULA is unknown.

Embryo-fetal toxicity and lactation: Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for 6 months after receiving their final dose of ZEJULA. Because of the potential for serious adverse reactions from ZEJULA in breastfed infants, advise lactating women to not breastfeed during treatment with ZEJULA and for 1 month after receiving the final dose.

Allergic reactions to FD&C Yellow No. 5 (tartrazine): ZEJULA capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

First-line Maintenance Advanced Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of all patients who received ZEJULA in PRIMA were thrombocytopenia (66%), anemia (64%), nausea (57%), fatigue (51%), neutropenia (42%), constipation (40%), musculoskeletal pain (39%), leukopenia (28%), headache (26%), insomnia (25%), vomiting (22%), dyspnea (22%), decreased appetite (19%), dizziness (19%), cough (18%), hypertension (18%), AST/ALT elevation (14%), and acute kidney injury (12%).

Common lab abnormalities (Grades 1-4) in ≥25% of all patients who received ZEJULA in PRIMA included: decreased hemoglobin (87%), decreased platelets (74%), decreased leukocytes (71%), increased glucose (66%), decreased neutrophils (66%), decreased lymphocytes (51%), increased alkaline phosphatase (46%), increased creatinine (40%), decreased magnesium (36%), increased AST (35%) and increased ALT (29%).

Maintenance Recurrent Ovarian Cancer

Most common adverse reactions (Grades 1-4) in ≥10% of patients who received ZEJULA in NOVA were nausea (74%), thrombocytopenia (61%), fatigue/asthenia (57%), anemia (50%), constipation (40%), vomiting (34%), neutropenia (30%), insomnia (27%), headache (26%), decreased appetite (25%), nasopharyngitis (23%), rash (21%), hypertension (20%), dyspnea (20%), mucositis/stomatitis (20%), dizziness (18%), back pain (18%), dyspepsia (18%), leukopenia (17%), cough (16%), urinary tract infection (13%), anxiety (11%), dry mouth (10%), AST/ALT elevation (10%), dysgeusia (10%), palpitations (10%).

Common lab abnormalities (Grades 1-4) in ≥25% of patients who received ZEJULA in NOVA included: decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%), and increase in ALT (28%).

On September 22, 2022 Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, reported that Laurence Reid, Ph.D., Chief Executive Officer, will participate in a fireside chat at the Jefferies Cell and Genetic Medicine Summit on Friday, September 30, 2022, at 10:00 a.m. ET in New York, NY (Press release, Decibel Therapeutics, SEP 22, 2022, View Source [SID1234621348]).

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A live webcast of the fireside chat may be accessed by visiting the Investors section of the Decibel Therapeutics website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the fireside chat.