The Daily Biotech Pulse: Novavax Retreats Amid Vaccine Issues, LumiraDx COVID Test Approved In India, Sesen Shines On Positive Bladder Cancer Review

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

Stocks In Focus

Novavax Shares React to Reports Of Manufacturing Issues With Its COVID-19 Vaccine

Novavax, Inc. NVAX shares are coming under pressure after Politico reported the company may be facing more serious manufacturing issues with its COVID-19 vaccine candidate. The company is finding it tough to meet the purity standards set forth by the Food and Drug Administration and its vaccine candidate could reach full licensure only by the end of 2022, the report said.

The company also announced data from the Phase 2 combo vaccination study carried out by Oxford University, using its vaccine as the second dose in a heterologous regimen. Separately, an SEC filing by the company showed Gregory Glenn, its President, R&D, sold 1,183 shares in the company at $170 per share.

The stock was slumping 18.16% to $131.40 in premarket trading.

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Molecular Partners to Present Positive Data For COVID-19 Treatment

Molecular Partners AG MOLN announced that it will present in vitro data describing the inhibition capabilities of ensovibep against COVID-19 variants of concern at the International Society for Influenza and other Respiratory Virus Diseases and World Health Organization COVID-19, Influenza and RSV: Surveillance-Informed Prevention and Treatment Conference.

Akero's NASH Drug Gets FDA's Fast Track Designation

Akero Therapeutics, Inc. AKRO announced that the FDA has granted fast track designation to its lead program investigating efruxifermin for the treatment of non-alcoholic steatohepatitis.

The stock was advancing 3.54% to $22.21 in premarket trading.

Sesen Bio Gains On FDA Granting Request For Type A Meeting to Discuss Vicienum CRL

Sesen Bio, Inc. SESN disclosed in a filing that on Tuesday the FDA granted its request for a Type A meeting to discuss the chemistry, manufacturing and controls issues raised in the FDA's complete response letter regarding its biologics license application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The CMC Type A Meeting has been scheduled for Oct. 29.

The stock was up 14.85% to $1.16 in premarket trading.

Merck Recalls a Lot of Antibiotic On Report of Contamination With Glass Piece

Merck & Co., Inc. MRK said it is voluntarily recalling one lot of Cubicin(daptomycin for injection) 500 mg for intravenous use. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution.

Approximately 22,000 vials are affected by this recall.

ObsEva Announces Positive Data For Linzagolix In Uterine Fibroids and Severe Adenomyosis

ObsEva SA OBSV announced the presentation of clinical data from PRIMROSE Phase 3 study of linzagolix for the treatment of uterine fibroids as well as final data from a pilot study of linzagolix for the treatment of severe adenomyosis at the American Society for Reproductive Medicine 2021 Scientific Congress & Expo.

Once daily treatment of 200 mg linzagolix without add-back therapy, or ABT, reduced uterine volume by 39% after 24 weeks. However, co-administration of hormonal ABT after 24 weeks counteracted the uterine volume reducing effects at 52 weeks.

Additionally, a high dose of 200 mg linzagolix reduced uterine volume by 55% from baseline at 12 weeks and 32% from baseline at 24 weeks after continued treatment with 100 mg linzagolix. Pelvic pain was markedly reduced at 12 and 24 weeks with initial signs of reduction after 4 weeks. Overall, significant improvements in quality of life were reported.

The stock was adding 2.19% to $2.18 in premarket trading.

LumiraDx COVID-19 Antigen Test Authorized For Emergency Use In India

LumiraDx LMDX announced it has received emergency use approval by India's Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

The stock was skyrocketing 56.58% to $13.20 in premarket trading.

Satsuma, Precision Biosciences React to Fund Buying, Insider Buying

Commodore Capital said in a filing that it held 3.209 million shares of Satsuma Pharmaceuticals, Inc. STSA. The fund also bought 162,194 shares of the company.

The stock was up 9.16% to $5.60 in premarket trading.

Precision BioSciences, Inc. DTIL revealed in a filing, CEO Michael Amoroso exercised stock options and bought 864,208 shares in the biopharma.

In premarket trading, the stock was adding 3.63% to $10.29.

Earnings

Swiss pharma giant Roche Holding AG RHHBY reported group sales growth of 8% in constant exchange rates for the nine months ended Sept. 30. Pharma division sales grew 5% and diagnostics division sales climbed 18%. The company raised the 2021 sales guidance to mid-single digit growth from the previous estimate of low to mid-single digit growth. The company expects core earnings per share to grow broadly in line with the sales growth.

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

On The Radar

Clinical Readouts

28th Annual Congress of the European Society of Gene and Cell Therapy Presentations

Tenaya Therapeutics, Inc. TNYA: new preclinical data for TN-201, its AAV-based gene therapy product candidate for patients carrying mutations of the MYBPC3 gene.

Rocket Pharmaceuticals, Inc. RCKT: interim results from the Phase 1/2 study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I

Earnings

Abbott Laboratories ABT (before the market open)
Biogen Inc. BIIB (before the market open)

IPOs

Pennsylvania-based Context Therapeutics, Inc. priced its initial public offering of 5 million shares at $5 per share, for raising gross proceeds of $25 million. The company's shares will begin trading on the Nasdaq under the ticker symbol CNTX. Context is a clinical-stage biopharma developing therapies for women living with cancer.