The Daily Biotech Pulse: Lyra Gains On Positive Regulatory Outcome, FDA Nod For Pfizer's Prevnar Vaccine, Merck Inks COVID-19 Treatment Supply Deal With US

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 8)

• Agios Pharmaceuticals, Inc. AGIO
• Alkermes plc ALKS
• AngioDynamics, Inc. ANGO (announced 510(k) clearance for the device for the non-surgical removal of thrombi or emboli from the vasculature)
• Apellis Pharmaceuticals, Inc. APLS
• Atossa Therapeutics, Inc. ATOS (gained in the run up to data presentation)
• Dicerna Pharmaceuticals, Inc. DRNA
• Novo Nordisk A/S NVO
• Oramed Pharmaceuticals Inc. ORMP (announced over 50% enrollment in the Phase 3 study of its oral insulin capsule ORMD-0801 for type 2 diabetes)
• Paratek Pharmaceuticals, Inc. PRTK
• Protagonist Therapeutics, Inc. PTGX
• Sesen Bio, Inc. SESN
• Verastem, Inc. VSTM

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 8)

• Angion Biomedica Corp. ANGN
• Biophytis SA BPTS
• Sigilon Therapeutics, Inc. SGTX

Stocks In Focus

Lyra Therapeutics Announces Positive End-of-Phase 2 Meeting With FDA Over Lead Drug For The Treatment of Chronic Rhinosinusitis

Lyra Therapeutics, Inc. LYRA announced the successful outcome of an end-of-Phase 2 meeting with FDA for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis.The company said along with the FDA it established key elements of the Phase 3 program to support a 505(b)(2) new drug application for LYR-210 for the treatment of CRS.

The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms of CRS: nasal blockage, nasal discharge, and facial pain. Based on the agency's suggestion, Lyra intends to enroll a total of approximately 350 subjects split into two replicate, largely concurrent Phase 3 clinical trials, each powered to >95% to detect statistical significance. Both studies will evaluate a 7500µg dose of LYR-210, and additional key clinical aspects of the studies will also be the same.

"Following our successful End of Phase 2 meeting with the FDA, we believe that we have a clear path forward to advance LYR-210's clinical development for the treatment of CRS," the company said.

The stock gained 21.73% to $9.58 in after-hours trading.

Pfizer Announces FDA Approval For Vaccine Against 20 Strains of Bacteria

Pfizer, Inc. PFE said the FDA has approved Prevnar 20, Pneumococcal 20-valent Conjugate Vaccine, for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.

Following the FDA approval, the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices is expected to meet in October to discuss and update recommendations on the safe and appropriate use of pneumococcal vaccines in adults.

Transmedics Announces Positive Results From Study of OCS Liver System That Preserves Donor Organs

TransMedics Group, Inc. TMDX announced that the complete results of the OCS Liver PROTECT Trial were presented virtually at the American Transplant Congress, showing the study met its primary effectiveness endpoint and demonstrated a significant reduction in early allograft dysfunction with OCS.

OCS preserved livers also demonstrated a significant reduction in histopathological evidence of IR injury after reperfusion and significant attenuation of reperfusion syndrome in the recipient. OCS use was also associated with significant reduction of ischemic biliary complications at one year, a leading cause of graft failure after liver transplant.

The stock rallied 9.35% to $28.90 in after-hours trading.

SQZ to Present Positive Pre-clinical Results For Autoimmune Diseases Program

SQZ Biotechnologies Company SQZ said it is presenting preclinical results from the Tolerizing Antigen Carrie – TAC - program demonstrating that its engineered TACs can drive antigen-specific immune tolerance through key mechanisms relevant to many complex autoimmune diseases.

In models of Type 1 diabetes, SQZ TACs were able to delete antigen-specific T cells, without causing non-specific immune suppression, ultimately preventing hyperglycemia. Importantly, SQZ TACs increased antigen-specific regulatory T cells that exerted potent bystander suppression, showing the ability to suppress pathogenic T cells with different autoantigen specificities. Together, these results suggest that SQZ TACs are a versatile platform for inducing antigen-specific immune tolerance, the company said.

The data will be presented Thursday at the 2021 Federation of Clinical Immunology Sciences annual meeting.

The stock was up 2.54% to $13.74% in premarket trading Wednesday.

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

Merck Agrees to Supply COVID Treatment to U.S.

Merck & Co., Inc. MRK announced it has entered into a procurement agreement with the U.S. government for molnupiravir. Molnupiravir is currently being evaluated in a Phase 3 clinical trial, the MOVe-OUT study, for the treatment of non-hospitalized patients with laboratory-confirmed COVID-19 and at least one risk factor associated with poor disease outcomes. Merck is developing molnupiravir in collaboration with Ridgeback Biotherapeutics.

Merck shares were up 0.76% at $72.96 in premarket trading Wednesday.

Sonnet Gets U.S. Patent For Technology Targeting Tumors

Sonnet BioTherapeutics Holdings, Inc. SONN said the U.S. Patent and Trademark Office, or USPTO, has issued U.S. Patent No. 11,028,166 entitled, "Albumin Domain Fusion Proteins."The patent covers Sonnet's Fully Human Albumin Binding technology and includes therapeutic fusion proteins that utilize FHAB for tumor targeting and retention and provide extended pharmacokinetics, and the patent carries a term effective until March 2039.

The stock moved up 7.19% to $1.64 in after-hours trading.

Kiniksa Issued U.S. Patent For Rilonacept To Treat Swelling of Heart Membrane

Kiniksa Pharmaceuticals, Limited KNSA announced that the USPTO issued a patent covering methods of using Arcalyst (rilonacept) in the treatment of recurrent pericarditis.The patent issued will expire on March 11, 2039. Kiniksa has exclusive rights to this patent under the Arcalyst License Agreement.

The stock rose 2.18% to $14.50 in after-hours trading.

Offerings

Aclaris Therapeutics, Inc. ACRS said it intends to offer and sell, subject to market conditions, $75 million in shares of its common stock in an underwritten public offering. All of the shares of common stock to be sold in the offering will be offered by Aclaris. The company reported Tuesday positive preliminary results from its Phase 2a trial evaluating ATI-1777 for moderate to severe atopic dermatitis

On The Radar

Clinical Readouts/Presentations

Atossa Therapeutics, Inc. ATOS will hold a webinar at 11 am to release and discuss final data from its Phase 2 study of Endoxifen administered to breast cancer patients prior to surgery.