The Daily Biotech Pulse: Allakos Slips Negative Late-Stage Data, Pfizer & Merck Announce Fresh COVID Pill Deal With UK, Regulatory Setback For Takeda

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Allakos's Lirentelimab Flunks Late-Stage Studies In Patients With Inflammation In Digestive Tract

Allakos, Inc. ALLK announced data from ENIGMA 2 Phase 3 study of lirentelimab in patients with biopsy confirmed eosinophilic gastritis and/or eosinophilic duodenitis and KRYPTOS Phase 2/3 study of lirentelimab in patients with biopsy-confirmed eosinophilic esophagitis.

Both ENIGMA 2 and KRYPTOS studies met their histologic co-primary endpoints, but did not achieve statistical significance on the patient reported symptomatic co-primary endpoints.

The stock was down 7.69% to $77.90 in premarket trading.

FDA Imposes Clinical Hold On Injectable Form Of Gilead's HIV Drug Candidate Due to Concerns Over Vial Quality

Gilead Sciences, Inc. GILD announced that the U.S. Food and Drug Administration has placed a clinical hold on the use of injectable lenacapavir in borosilicate vials in all ongoing clinical studies for HIV treatment and HIV pre-exposure prophylaxis.

The FDA's clinical hold is due to emerging concerns about the compatibility of vials made of borosilicate glass with lenacapavir solution, which could potentially lead to the formation of sub-visible glass particles in the solution of lenacapavir. Dosing of oral formulations of lenacapavir will continue, Gilead said.

The company remains confident about the future potential of lenacapavir and is committed to resolving this vial quality issue.

Click here to access Benzinga's FDA Calendar

Syndax's Blood Cancer Drug Gets Orphan Drug Designation

Syndax Pharmaceuticals, Inc. SNDX announced that the European Commission has granted orphan drug designation to SNDX-5613, its highly selective oral menin inhibitor, for the treatment of acute myeloid leukemia.

Repro Gets FDA Clearance For Use Of Infusion System to Two Additional Drugs

Repro Med Systems, Inc. KRMD announced FDA 510(k) clearance that expands on-label use of the FREEDOM60 Infusion System to two additional subcutaneous Ig medications, Cutaquig, manufactured by Octapharma, and Xembify, manufactured by Grifols, S.A. GRFS.

The stock was advancing 1.31% to $3.1 in premarket.

Novartis's Sandoz Unit Files For Approval Of Cancer Biosimilar Drug In Europe

Novartis AG's NVS Sandoz generic unit has submitted a marketing authorization application for a proposed biosimilar trastuzumab, developed by EirGenix, Inc. to the European Medicines Agency.

Trastuzumab is a monoclonal antibody used for the treatment of human epidermal growth factor receptor 2 positive breast cancer and metastatic gastric cancers

Novavax Says WHO Vaccine Experts Recommend Use Of COVID-19 Vaccine, Commences Booster Dose Testing

Novavax, Inc. NVAX said the WHO Strategic Advisory Group of Experts on Immunization has published its interim recommendations for use of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

The recommendations follow Emergency Use Listing of the vaccine by WHO, which will be manufactured and marketed as Nuvaxovid COVID-19 vaccine by Novavax in Europe and other markets, and as Covovax in India and licensed territories by the Serum Institute of India Pvt. Limited.

Separately, the company said the first booster doses of NVX-CoV2373 have been administered in an extension of the company's PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and efficacy of a heterologous or homologous third dose of NVX-CoV2373.

The stock was down 0.88% at $188.39 in premarket trading.

Takeda's TAK-721 Application Shot Down With A Complete Response Letter

Takeda Pharmaceutical Company Limited TAK announced that it has received a complete response letter from the FDA for its new drug application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis, a chronic inflammatory disease of the esophagus.

The CRL indicates the FDA has completed its review of the TAK-721 NDA and determined that it cannot be approved in its present form. In addition, the FDA recommended an additional clinical study in order to help resolve FDA feedback.
The stock was down 0.58% at $13.79 in premarket trading.

Merck, Pfizer Secure Orders to Buy Additional Doses of Oral COVID-19 Pill

Merck & Co., Inc. MRK and Ridgeback Biotherapeutics announced that the U.K. government will purchase an additional 1.75 million patient courses of molnupiravir, its investigational oral antiviral COVID-19 medicine. In the U.K., Lagevrio is the planned trademark for molnupiravir.

With this additional procurement agreement, which follows a previously announced agreement for 480,000 courses of treatment, the U.K. government has now committed to purchase a total of 2.23 million courses of molnupiravir.

Pfizer, Inc. PFE announced an additional agreement with the U.K. government to supply an additional 2.5 million treatment courses of its investigational candidate Paxlovid, subject to local authorization. This is in addition to the 250,000 treatment courses previously contracted by the U.K. government, pending authorization and recommendation for use, bringing the full amount of treatment courses to 2.75 million.

Merck shares were up 1.14% to $76.40 in premarket trading and Pfizer was seen edging up 0.42% to $59.20.

Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates

Tyra Gains On Institutional Buying

Tyra Biosciences, Inc. TYRA announced in a filing with the SEC that Boxer Capital, a 10% owner in the company, bought 125,000 shares in the company.

The stock was advancing 3.78% to $12.90 in premarket trading.

IPOs

Langhorne, Pennsylvania-based NexGel, Inc. NXGL priced its initial public offering of 2.585 million units, with each unit consisting of one common shares and one warrant to purchase one share of its common stock. Each share of common stock is being sold together with one warrant to purchase one share of common stock with an exercise price of $5.50 per share at a combined offering price of $5.50, for gross proceeds of approximately $14.2 million.

The company manufactures high water content, electron beam cross-linked, aqueous polymer hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. The shares and warrants will begin trading on the Nasdaq under the symbols NXGL and NXGLW, respectively.