On February 4, 2021 Revolution Medicines, Inc. (Nasdaq: RVMD) reported the pricing of its underwritten public offering of 5,797,101 shares of common stock at a public offering price of $45.00 per share, before underwriting discounts and commissions (Press release, Revolution Medicines, FEB 4, 2021, View Source [SID1234575013]). All of the shares of common stock are being offered by Revolution Medicines. In addition, Revolution Medicines has granted the underwriters a 30-day option to purchase up to an additional 869,565 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Revolution Medicines, are expected to be approximately $260.9 million, excluding any exercise of the underwriters’ option to purchase additional shares. The offering is expected to close on February 8, 2021, subject to customary closing conditions.

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J.P. Morgan, Cowen, SVB Leerink and Guggenheim Securities are acting as the joint book-running managers for the offering.

A registration statement relating to the shares being sold in this offering was declared effective by the Securities and Exchange Commission on February 3, 2021. The offering is being made only by means of a prospectus, copies of which may be obtained, when available, from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA, 02110, by telephone at 1-800-808-7525, ext. 6105, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 4, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that the United States Food and Drug Administration (FDA) has granted fast track designation to TH1902 as a single agent for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy (Press release, Theratechnologies, FEB 4, 2021, View Source [SID1234574991]).

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"Receiving fast track designation for TH1902 at this early stage of development is a significant recognition for our SORT1+ Technology and further supports the future development of TH1902. The designation, which applies to all solid tumours expressing sortilin, also highlights the broad applicability and immense medical need for innovative, targeted, and potentially more effective and better-tolerated therapies for cancer," said Dr. Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies.

On February 4, 2021 AstraZeneca reported that British drugmaker and researchers from the UCL Division of Infection & Immunity will collaborate on two projects which will aim to contribute to the development of new cancer treatments (Press release, AstraZeneca, FEB 4, 2021, View Source [SID1234574705]).

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The new research collaborations will investigate immune checkpoints – key biochemical pathways that regulate the body’s immune responses.

Although immune checkpoints help to keep the body’s immune response at normal levels by not harming healthy cells, they can also block specialist immune cells from attacking and destroying cancer cells.

Over the last decade, the emergence of checkpoint inhibitor drugs have revolutionised cancer treatment and demonstrated benefit in clinical results for patients with solid tumours.

Meanwhile, the two AstraZeneca/UCL projects will focus on increasing understanding of immune checkpoint mechanisms and how to manipulate them.

The ultimate aim of the projects will to be to aid the development of new immunotherapy approaches.

AstraZeneca will provide a number of compounds for the projects, while UCL will use unique preclinical models and an array of molecular and cell biology techniques to study these pathways.

"These collaborations with AstraZeneca will bring together some of the very best minds in immuno-oncology," said Dr Kathryn Walsh, executive director, office of the Vice-Provost (Enterprise), UCL.

"Working together, experts from both institutions will push the boundaries of our understanding of the role of the body’s immune system. In the future, these insights will play a valuable role in how we will be able to develop new treatments to help patients with solid tumours," she added.

On February 4, 2021 Bayer AG reported a $2 billion deal to resolve future legal claims that its widely used weedkiller Roundup causes cancer, the German company said on Wednesday (Press release, Bayer, FEB 4, 2021, View Source [SID1234574704]).

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Bayer has been struggling to finalize the settlement of claims that Roundup and other glyphosate-based herbicides cause non-Hodgkin’s lymphoma, a type of cancer. Bayer inherited the business and the litigation as part of a $63 billion acquisition of Monsanto in 2018.

The company has said that decades of studies have shown Roundup and glyphosate are safe for human use.

Wednesday’s settlement would cover future claims brought by individuals who have been diagnosed with non-Hodgkin’s lymphoma and were exposed to Roundup before their diagnosis. The settlement also includes benefits for people who were exposed to Roundup and develop the cancer in the future.

Roundup, which Monsanto first brought to the market in 1974, is widely used by farmers across the United States and Brazil, alongside crops that are genetically engineered to withstand the its herbicidal effect.

Glyphosate will remain on the market. Bayer agreed to seek permission from the U.S. Environmental Protection Agency to provide a reference link on labels so consumers can find scientific studies on the weedkiller.

Under the proposed plan, Bayer will provide $2 billion for a four-year period as compensation and to cover outreach and diagnostic assistance. Future claimants could receive up to $200,000 under the deal.

The parties can agree to extend the settlement period.

The company said the settlement amount was disclosed last year.

The agreement must be approved by U.S. District Court Judge Vince Chhabria in San Francisco.

Chhabria in June questioned the legality of a prior settlement plan that Bayer proposed, which envisioned creating a panel of scientists who would rule on the viability of claims.

Under the revised deal, anyone who does not make a claim during the four-year period would then be able to sue in court, according Elizabeth Cabraser, an attorney for the proposed class. She also said anyone diagnosed with non-Hodgkin’s lymphoma who does not like their compensation offer under the class plan can go to the court system and try for a better result.

In June, Bayer reached a wider $9.6 billion settlement that would resolve the bulk of the more than 100,000 U.S. lawsuits that were already filed over Roundup.

Bayer’s stock has been battered by the litigation, but also by billions of euros in writedowns, and a bleaker profit outlook, in large part related to the $63 billion Monsanto takeover.

The group last year announced 9.25 billion euros in impairment charges on agricultural assets and shocked markets by predicting a slight decline in core earnings per share in 2021 on weaker demand by farmers.

On February 4, 2021 Novartis reported that may have jumped out ahead of Merck KGaA with targeted lung cancer med Tabrecta, but the German drugmaker has evened the score (Press release, Merck KGaA, FEB 4, 2021, View Source [SID1234574703]).

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The FDA Wednesday cleared its drug Tepmetko in non-small cell lung cancer patients with MET exon 14 skipping mutations, whether or not they’ve received prior treatments. The mutation affects about 3% to 4% of NSCLC patients and creates an aggressive form of the disease.

Tepmetko will bear a list price of $20,898.60 for a 30-day supply, which is "within the range of other oral oncolytics for advanced NSCLC," a spokesperson said by email.

U.S. regulators based their decision on data from the phase 2 Vision trial, which showed Tepmetko could spur a benefit in 43% of patients. Previously treated patients continued to respond to the drug for a median 11.1 months, while those new to therapy responded for a median 10.8 months.

RELATED: Merck KGaA beats out Novartis with targeted lung cancer nod for Tepmetko in Japan

The FDA’s nod follows up on a positive decision from the Japanese Ministry of Health, Labour and Welfare, which last March became the first global regulator to green-light a MET inhibitor. Since then, though, the FDA has gotten in on the action with its May 2020 go-ahead for Tabrecta, and now Merck will be taking its product toe-to-toe with Novartis’ in the U.S.

While the Swiss pharma giant has the head start, Merck KGaA has its own advantage to tout: once-daily dosing. Tabrecta tablets are given twice daily at a 400 mg dose, while patients take two 225 mg Tepmetko tablets simultaneously just once per day.

"Our focus now is to ensure Tepmetko is accessible to patients in the United States and fully integrated into clinical practice, given the important advance it represents for indicated patients as an oral once-a-day precision medicine," said Danny Bar-Zohar, M.D., global head of development for Merck KGaA’s healthcare business.

RELATED: Novartis beats Merck KGaA to U.S. finish line with targeted lung cancer drug Tabrecta

To do that, though, first Merck KGaA will have to ramp up MET testing—a goal Novartis shares. Testing for the mutation is usually done as part of next-gen lung cancer sequencing, Ameet Mallik, EVP at Novartis Oncology U.S., said an interview last spring, and at that time, only about 35% of U.S. lung cancer patients were receiving that sequencing upfront.