On March 2, 2018 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with standard review the company’s New Drug Application (NDA) seeking marketing approval for solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA) (Press release, Jazz Pharmaceuticals, MAR 2, 2018, View Source;p=RssLanding&cat=news&id=2335912 [SID1234524340]). The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is December 20, 2018.

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"We believe this medicine will provide a meaningful option for patients living with excessive sleepiness due to narcolepsy or OSA, and we look forward to working with the FDA during the review process for solriamfetol," said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. "Jazz continues to invest in ongoing research, education and advocacy on behalf of the sleep community, including studying solriamfetol for the treatment of excessive sleepiness in other areas of unmet need, such as Parkinson’s disease."

The solriamfetol Phase 3 clinical program includes one study evaluating excessive sleepiness in adult patients with narcolepsy (TONES 2), two studies evaluating excessive sleepiness in adult patients with OSA (TONES 3 and TONES 4), and an open-label, long-term safety and maintenance of efficacy study (TONES 5) in the treatment of excessive sleepiness in patients with narcolepsy or OSA.

About OSA and Excessive Sleepiness
OSA is a prevalent disease (as high as 14% in men and 5% in women) with excessive sleepiness being a major presenting complaint in many cases.1-2 Excessive sleepiness in OSA is associated with impairments in cognitive function, safety, productivity, interpersonal relationships, and overall quality of life. Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep-related airway obstruction, with frequent improvement in excessive sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. It is estimated that excessive sleepiness persists in 13%–65% of people utilizing CPAP for OSA.3-5

About Narcolepsy
Narcolepsy is a debilitating neurological disorder characterized by excessive sleepiness, and the inability to regulate sleep-wake cycles normally.6 It affects an estimated one in 2,000 people in the United States, with symptoms typically appearing in early adulthood. It is estimated that more than 50% of patients with narcolepsy have not been diagnosed.7 Studies have shown it may take 10 years or more for people with narcolepsy to receive a correct diagnosis.8 Excessive sleepiness is the primary symptom of narcolepsy and is present in all people with the disorder.2 Excessive sleepiness is characterized by the inability to stay awake and alert during the day resulting in unplanned lapses into sleep or drowsiness.2,7,9

About Solriamfetol (JZP-110)
Solriamfetol (JZP-110) is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in development for treatment of excessive sleepiness in adult patients with narcolepsy, OSA, and Parkinson’s disease. In 2014, Jazz Pharmaceuticals acquired a license to develop and commercialize solriamfetol from Aerial Biopharma. Jazz Pharmaceuticals has worldwide development, manufacturing, and commercialization rights to solriamfetol, excluding certain jurisdictions in Asia. SK Biopharmaceuticals, the discoverer of the compound (also known as SKL-N05), maintains rights in 12 Asian markets, including Korea, China and Japan. Solriamfetol has orphan drug designation in the United States for narcolepsy.

On March 2, 2018 Heat Biologics, Inc. ("Heat") (Nasdaq: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial results for the fiscal year ended December 31, 2017 (Press release, Heat Biologics, MAR 2, 2018, View Source [SID1234524339]).

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"2017 was a significant year for Heat, as we gained traction on our pipeline developments for both Heat and our subsidiary, Pelican Therapeutics," said Jeff Wolf, CEO of Heat. "Our focus for 2018 will be to continue to generate and report on data to progress HS-110 into registrational trials, advance our PTX-35 into clinical trials, and secure partnerships to enhance our efforts. We look forward to continued progress as we continue to build a leading immunotherapy company."

Fiscal Year 2017 Corporate Highlights

On December 7, 2017, we received written responses from the FDA following a Type C meeting regarding the planned registrational HS-110 clinical trial design for the treatment of non-small cell lung cancer (NSCLC). The response focused on proposed Phase 3 trial designs, both single-arm and controlled, which the FDA agreed would be appropriate to support a registrational trial of HS-110. Clinical endpoints and post-marketing commitments were also discussed in the context of accelerated approval.

On October 30, 2017, Heat subsidiary Pelican Therapeutics ("Pelican") received the second tranche in the amount of $6.5 million of its $15.2 million CPRIT grant award. The CPRIT award supports the pre-clinical development, manufacturing and clinical development of a 70-patient Phase 1 clinical trial for PTX-35.

On September 27, 2017, we announced a manufacturing agreement with KBI Biopharma, Inc. a global biopharmaceutical contract development and manufacturing organization, for cGMP production of Pelican’s PTX-35 antibody and PTX-15 fusion protein.

On May 1, 2017, we announced the completion of the acquisition of an 80 percent controlling interest in Pelican.

On March 21, 2017, we reported promising interim results for the Phase 1b portion of the trial evaluating HS-110 in combination with Bristol-Myers Squibb’s checkpoint inhibitor, nivolumab (Opdivo), for the treatment of advanced NSCLC.

2018 Additional Development

On February 27, 2018, at the 2018 Keystone Symposia Conference, Immunological Memory: Innate, Adaptive and Beyond (X1), we presented interim results from our Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced NSCLC, whose cancers have progressed after treatment with one or more lines of therapy. Data are consistent with HS-110 mechanism-of-action, with tumor shrinkage and disease control demonstrated in a majority of evaluable patients. The HS-110 and nivolumab combination also shows durable responses in both difficult-to-treat, low TIL "cold tumor" patients, as well as low PD-L1 patients who typically do not respond to checkpoint inhibitors.

Fiscal Year 2017 Financial Highlights

Total operating expenses increased 10.4% to $14.9 million, compared to $13.5 million for the year ended December 31, 2016. For the year ended December 31, 2017, operating expenses are primarily comprised of research and development, general and administrative expenses, as well as change in the fair value of contingent consideration due to the Company’s acquisition of 80% controlling interest in Pelican during the year.

On March 2, 2019 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that the Company’s fourth quarter 2017 financial results will be released on Thursday, March 8, 2018 (Press release, Calithera Biosciences, MAR 2, 2018, View Source [SID1234535245]). Company management will host a conference call on Thursday, March 8, 2018 at 1:30 p.m. Pacific Time/ 4:30 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 3398144. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 day

On March 2, 2018 Celldex Therapeutics, Inc. (Nasdaq:CLDX) reported that upcoming investor events in March (Press release, Celldex Therapeutics, MAR 2, 2018, View Source [SID1234524337]).

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2017 Year-End Results and Conference Call/Webcast

Celldex will release fourth quarter and year-end 2017 financial results on Wednesday, March 7, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EST on the same day to discuss 2017 financial and business results and to provide an update on upcoming milestones for 2018.

The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 8296067.

A replay of the call will be available approximately two hours after the live call concludes through March 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 8296067. The webcast will also be archived on the Company’s website.

Upcoming Investor Conference

Anthony Marucci, Co-founder, President and Chief Executive Officer, will present a corporate overview at Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today upcoming investor events in March.

2017 Year-End Results and Conference Call/Webcast

Celldex will release fourth quarter and year-end 2017 financial results on Wednesday, March 7, 2018 after the U.S. financial markets close. Celldex executives will host a conference call at 4:30 p.m. EST on the same day to discuss 2017 financial and business results and to provide an update on upcoming milestones for 2018.

The conference call and presentation will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 8296067.

A replay of the call will be available approximately two hours after the live call concludes through March 15, 2018. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 8296067. The webcast will also be archived on the Company’s website.

Upcoming Investor Conference

Anthony Marucci, Co-founder, President and Chief Executive Officer, will present a corporate overview at the Cowen and Company 38th Annual Health Care Conference in Boston on Monday, March 12, 2018 at 2:10 p.m. EDT.

A live webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for seven days following the event.

A live webcast of the presentation will be available on the "Events & Presentations" page of the "Investors & Media" section of the Celldex website. A replay will be available for seven days following the event.

On March 1, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the company’s anti-CTGF antibody, pamrevlumab, for the treatment of patients with locally advanced unresectable pancreatic cancer (Press release, FibroGen, MAR 1, 2018, View Source;p=RssLanding&cat=news&id=2335711 [SID1234524303]).

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This follows review of the Phase 2 clinical trial evaluating pamrevlumab in combination with gemcitabine and nab-paclitaxel and represents recognition by the FDA that pamrevlumab has the potential to address an unmet medical need for this disease.

"There are no approved treatment options for patients with locally advanced pancreatic cancer, who face a short life expectancy. We are encouraged by our Phase 2 study results, where the combination of pamrevlumab with chemotherapy changed eligibility for surgical resection in a majority of treated patients who were previously not candidates for surgery," said Peony Yu, M.D., FibroGen’s Chief Medical Officer. "This designation is an important milestone for our pamrevlumab program and has the potential to speed our ability to advance pamrevlumab to patients."

About Fast Track Designation
Fast Track designation is intended to facilitate the development and review of drugs used to treat serious conditions and to fill an unmet medical need. Fast Track designation enables the company to have more frequent interactions with the FDA throughout the drug development process, so that an approved product can reach the market expeditiously.

About Locally Advanced Pancreatic Cancer
In locally advanced pancreatic cancer (LAPC), the patient’s tumor typically involves structures, particularly blood vessels that are closely associated with the pancreas such as the superior mesenteric artery and superior mesenteric vein. Involvement of the cancer around these blood vessels precludes surgical removal of the tumor. Patients with unresectable LAPC have a median survival of six to 10 months, only slightly better than patients with metastatic pancreatic cancer, and only 20 percent of newly diagnosed patients are classified as having resectable disease. Patients who have their tumor surgically removed have a much better prognosis with median survival of approximately 23 months with some patients being cured.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Fibrosis is characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. In desmoplastic, or fibrotic cancers, such as pancreatic cancer, fibrous tissue promotes abnormal proliferation of tumor cells and associated stromal cells. Pamrevlumab is advancing towards Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and pancreatic cancer, and is currently in a Phase 2 trial for Duchenne muscular dystrophy (DMD). In Phase 2 clinical studies conducted to date, pamrevlumab has demonstrated a good safety and tolerability profile. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.