The Daily Biotech Pulse: Avenue Tumbles On Negative Adcom Verdict, Moderna's Expanded Deal With Rovi, Gilead Takes Equity Stake In Hookipa

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

Stocks In Focus

Hookipa Gets $15M Upfront Payment And Equity Investment From Gilead Following Amended HIV Study Agreement

HOOKIPA Pharma Inc. HOOK said it has entered into an amended and restated collaboration and license agreement with Gilead Sciences, Inc. GILD to advance the development of an arenaviral immunotherapy as a component of a potential functional curative regimen for HIV.

Under the amended and restated agreement, HOOKIPA is responsible for advancing the HIV program through the completion of a Phase 1b clinical trial, with funding from Gilead through a $15 million upfront payment and equity purchases. At the completion of the Phase 1b trial, Gilead has the exclusive right to assume further development of the program.

HOOKIPA shares were jumping 38.81% to $1.86 in premarket trading.

Mirati's Regulatory Application For KRAS Inhibitor Adagrasib Accepted For Review

Mirati Therapeutics, Inc. MRTX said the U.S. Food and Drug Administration accepted the new drug application for adagrasib for the treatment of patients with non-small cell lung cancer harboring the KRAS G12C mutation who have received at least one prior systemic therapy.

The PDUFA date for adagrasib is Dec. 14, 2022.

The stock was moving down 6.88% to $100 in premarket trading, apparently in disappointment over the NDA not getting priority review designation. Amgen, Inc. AMGN already has a competing drug in the market, which was approved by the FDA in May 2021.

Click here to access Benzinga's FDA Calendar

Avenue's Pain Drug Data Submitted For Regulatory Review Inadequate To Support Approval, Adcom Says

Avenue Therapeutics, Inc. ATXI said a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol voted that the company has not submitted adequate information to support the proposition that benefits of the product outweigh the risks for the management of acute pain severe.

The Adcom meeting was called for by the FDA as it sought inputs needed for the Office of New Drugs to reach a decision on Avenue's formal dispute resolution request.

The stock was slumping 54.6% to 26.50 cents in premarket trading.

AstraZeneca Autoimmune Disorder Drug Approved In Europe

AstraZeneca plc AZN said its Saphnelo has been approved in the European Union as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus, despite receiving standard therapy.

AstraZeneca has an agreement in place to pay Bristol-Myers Squibb Company BMS a low- to mid-teens royalty for sales, depending on the geography. The U.K. company had licensed the drug from Medarex, which has since then been acquired by Bristol-Myers Squibb.

Bristol-Myers Squibb Announces Positive Phase 3 Data For Mavacamten In Heart Disease

Bristol-Myers Squibb announced that the Phase 3 study evaluating mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy, who are eligible for septal reduction therapy, met its primary endpoint at Week 16. The safety of mavacamten was consistent with previous studies.

Global Blood's Sickle Cell Anemia Drug Receives Nod In Europe

Global Blood Therapeutics, Inc. GBT said the European Commission has granted marketing authorization for Oxbryta for the treatment of hemolytic anemia due to sickle cell disease in adult and pediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide.

Oxbryta was approved by the U.S. FDA in November 2019 and it has since then received label expansion for use in the pediatric population, too.

Moderna Expands Base In Asia, Announces Expanded Agreement With Rovi

Moderna, Inc. MRNA said it plans to add four new subsidiaries in Malaysia, Taiwan, Singapore, and Hong Kong, as it continues to scale up the manufacturing and distribution of its COVID-19 vaccine and future mRNA vaccines and therapeutics.

Separately, Moderna and its CDMO Rovi announced an expanded agreement for a 10-year collaboration to increase capacities for the compounding, aseptic filling, inspection, labeling, and packaging at Rovi's facilities in Spain.

Moderna shares were down 2.06% at $148 in premarket trading.

Sage, Biogen Report Positive Late-Stage Data For Depression Drug

Sage Therapeutics, Inc. SAGE and Biogen Inc. (NASDAQ: BIIB) announced the Phase 3 CORAL Study in people with major depressive disorder met the trial objectives, demonstrating a rapid and statistically significant reduction in depressive symptoms at Day 3 and over the two-week treatment period, achieving the primary and key secondary endpoints.

Sage shares were moving down 5.75% to $41 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates

Earnings

Pacific Biosciences of California, Inc. PACB said its fourth-quarter revenues climbed 33% year-over-year to $36 million but the net loss, on a non-GAAP basis, widened from 12 cents per share to 30 cents per share. The loss was also wider than the consensus estimate.

In premarket trading, the stock was retreating 10.81% to $10.15.

Clearpoint Neuro CLPT announced preliminary fourth-quarter revenues of $4.3 million, up 15% year-over-year. This is in line with the consensus estimate. For 2022, the company expects revenues of $20 million to $22 million, ahead of the $20 million consensus estimate.

The stock was advancing 8.98% to $9.10 in premarket trading.

Masimo Corporation MASI said its fourth-quarter product revenues climbed 11% to $327.6 million and non-GAAP net income came in at $1.21 per share, up from 98 cents per share a year ago.

The company guided 2022 product revenues to $1.35 billion and non-GAAP EPS to $4.34.

The stock was slipping 13.49% to $197.98 in premarket trading.

On The Radar

Earnings

Blueprint Medicines Corporation BPMC (before the market open)
Avanos Medical, Inc. AVNS (before the market open)
Alkermes plc ALKS (before the market open)
10x Genomics, Inc. TXG (after the market close)
Outset Medical, Inc. OM(after the market close)

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