The Daily Biotech Pulse: FDA Rejection For Protalix, Amgen Q1 Trail Estimates, Pfizer Goes Shopping

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 April 27)

• Aldeyra Therapeutics, Inc. ALDX (announced a positive readout for allergic conjunctivitis drug)
• Celcuity Inc. CELC
• Celldex Therapeutics, Inc. CLDX)
• Harvard Bioscience, Inc. HBIO
• Ibere Pharmaceuticals IBER
• Insulet Corporation PODD
• Integra LifeSciences Holdings Corporation IART
• IRadimed Corporation IRMD
• Lantheus Holdings, Inc. LNTH
• MacroGenics, Inc. MGNX
• Madrigal Pharmaceuticals, Inc. MDGL
• NeuroPace, Inc. NPCE (IPOed Thursday)
• NovoCure Limited NVCR
• PLx Pharma Inc. PLXP
• Seelos Therapeutics, Inc. SEEL
• ShockWave Medical, Inc. SWAV
• Treace Medical Concepts, Inc. TMCI (IPOed Friday)
• Verastem, Inc. VSTM
• Vericel Corporation VCEL
• Zentalis Pharmaceuticals, Inc. ZNTL

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 27)

• Akoya Biosciences, Inc. AKYA
• Decibel Therapeutics, Inc. DBTX
• Finch Therapeutics Group, Inc. FNCH
• Longboard Pharmaceuticals, Inc. LBPH
• Mesoblast Limited MESO
• Osmotica Pharmaceuticals plc OSMT

Stocks In Focus

FDA Panel Votes In Favor of Maintaining Accelerated Approval of Tecentriq-Chemo Combo For Breast Cancer

Roche Holding AG RHHBY announced the U.S. Food and Drug Administration's Oncologic Drugs Advisory Committee voted 7 to 2 in favor of maintaining accelerated approval of Tecentriq, in combination with chemotherapy, for the treatment of adults with unresectable, locally advanced or metastatic triple-negative breast cancer, whose tumors express PD-L1, as determined by an FDA-approved test.

The ODAC meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals.

Shockwave Says CMS Recommends Incremental Payment For Technology to Treat Severely Calcified Cardiovascular Disease

Shockwave said the Centers for Medicare and Medicaid Services has recommended that coronary intravascular lithotripsy cases be eligible for incremental payment through a New Technology Add-on Payment from CMS, when performed in the hospital inpatient setting.

Shockwave develops intravascular lithotripsy to treat severely calcified cardiovascular disease.

The proposed annual rule is now open for public comment and is expected to be finalized and in effect by Oct. 1, the company said.

Protalix Handed Down Complete Response Letter For Regulatory Application For Fabry Disease Treatment

Protalix BioTherapeutics, Inc. PLX and partner Chiesi announced that they received a complete response letter from the FDA regarding the biologics license application, seeking accelerated approval of pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease.

The stock was plunging 36.19% to $3.72 in premarket trading Wednesday.

Pfizer Buys Privately-held Infectious Disease Company Amplyx

Pfizer Inc. PFE said it has acquired Amplyx Pharmaceuticals, Inc., a privately-held company developing therapies for debilitating and life-threatening diseases that affect people with compromised immune systems. Amplyx's lead compound, Fosmanogepix is a novel investigational asset under development for the treatment of invasive fungal infections.

The company did not disclose the financial terms of the deal.

DermTech to Collaborate With Stanford Medical School For Monitoring Patients With Skin Disorder

DermTech, Inc. DMTK announced a collaboration with researchers from the Stanford University School of Medicine on research titled, "A Study of Longitudinal Non-Invasive Cytokine Monitoring in Patients with Hidradenitis Suppurativa."

Hidradenitis suppurativa is a chronic skin condition featuring lumps in places such as the armpits or groin.

This collaboration will use DermTech's precision genomics and personalized dermatology approaches to improve the understanding of dermatological diseases.

The stock slipped 8.96% to $41.64 in after-hours trading after jumping 11.13% to $45.74 in regular trading.

Provention Bio Says FDA Deems Diabetes Drug Not Comparable With Lily's Historical Product Used In Bridging Study

Following an informal meeting with the FDA last week regarding the biologic license application for Type 1 diabetes drug teplizumab, Provention Bio, Inc. PRVB said the regulatory agency deemed that the pharmacokinetic profiles of the two drug products evaluated in the bridging study conducted in healthy volunteers are not comparable.

The purpose of this meeting was to discuss the FDA's considerations, thus far, regarding comparability between Provention's proposed commercial product and drug product used historically in clinical trials originating from drug substance manufactured by Eli Lilly and Company LLY over a decade ago.

Provention reiterated the FDA's pharmacokinetic comparability considerations are likely to result in a delay in potential BLA approval timelines and that the specifics of such delay will depend upon the outcome of ongoing discussions with the FDA to find a solution.

The stock fell 5.56% to $7.30 in after-hours trading.

BioVie to Buy Assets of Privately-held Neurology-focused Biopharma NeurMedix

BioVie Inc. BIVI announced the acquisition of the biopharmaceutical assets of NeurMedix, Inc., a San Diego based privately held clinical-stage pharma focused on novel therapeutic assets for the treatment of neurodegenerative and neurological disorders, as well as certain cancers.

Under the terms of the agreement, BioVie will pay to NeurMedix consideration consisting of 8.361 million newly issued BioVie shares and about $3 million cash at closing, an additional $7.3 million cash payment after all contemplated clinical programs have been funded and a pivotal Phase 3 clinical trial for NuerMedix' lead drug candidate, NE3107, has met its primary endpoints.

NeurMedix is also eligible to receive additional shares over time as various significant clinical, regulatory, and commercial milestones are met. The transaction is expected to close in June 2021.

The stock slumped 16.56% to $17.94 in after-hours trading.

Calliditas' Kidney Inflammation Drug Accepted For Priority Review By FDA

Calliditas Therapeutics AB CALT said the FDA has accepted the submission and granted priority review for the new drug application for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy. The FDA has set a PDUFA goal date of Sept. 15.

The stock was up 9.98% to $31.63 in premarket trading Wednesday.

Earnings

Sanofi's SNY first-quarter sales fell 4.3%, while its business EPS increased 5.2%. The company reaffirmed its full-year guidance that calls for high single digit growth in business EPS at constant exchange rate.

Amgen Inc. AMGN said its first-quarter revenues fell 4% to $5.9 billion and non-GAAP EPS decreased 12% to $3.70, while analysts, on average, had estimated EPS of $4.05. The company reaffirmed its full-year revenue and non-GAAP EPS guidance.

Separately, the company said it has agreed with the FDA's proposed post-marketing requirement to conduct a multi-center randomized clinical trial to compare the safety and efficacy of Lumakras at 960 mg once daily versus a lower daily dose of the drug. Lumakras is being evaluated in KRAS G12C-mutant advanced non-small cell lung cancer.

Based on the preclinical, pharmacokinetic, and clinical data, Amgen intends to proceed with the previously disclosed study comparing 960 mg once daily to a 240 mg once daily dose.

In after-hours trading, the stock lost 3.38% to $246.50.

Offerings

Benitec Biopharma Inc. BNTC announced that, due to demand, the underwriter has agreed to increase the size of the previously announced offering of 3.036 million shares of common stock at a price of $4.25 per share, for raising gross proceeds of $12.9 million. The offering is expected to close on or about April 30, subject to satisfaction of customary closing conditions.

The stock slipped 20.44% to $4.36 in after-hours trading.

Aldeyra announced that it intends to offer and sell, subject to market and other conditions, $125 million of shares of its common stock in an underwritten public offering. All of the shares in the offering are to be sold by Aldeyra, with net proceeds to be used for the preparation of a potential NDA submission for its lead compound, reproxalap, among other things.

The stock lost 3.64% to $14.31 in after-hours trading.

On The Radar

Clinical Readouts

Trillium Therapeutics Inc. TRIL will host its virtual R&D Day for analysts and investors at 10 am to 1 pm, wherein it will provide a clinical update for TTI-622 in refractory lymphoma or multiple myeloma, and TTI-621 in diffuse Large B-cell Lymphoma (DLBCL), cutaneous T-cell lymphoma.

Earnings

Boston Scientific Corporation BSX (before the market open)
Surmodics, Inc. SRDX (before the market open)
Integra LifeSciences Holdings Corporation IART (before the market open)
Alkermes plc ALKS (before the market open)
Apellis Pharmaceuticals, Inc. APLS (after the close)
Alimera Sciences, Inc. ALIM (after the close)
OPKO Health, Inc. OPK (after the close)
Hologic, Inc. HOLX (after the close)
Viking Therapeutics, Inc. VKTX (after the close)
MiMedx Group, Inc. MDXG (after the close)