The Daily Biotech Pulse: Novartis COVID-19 Drug Readout, Merck And Roche Earnings, 3 IPOs

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 Feb. 3)

• 9 Meters Biopharma Inc NMTR
• Anavex Life Sciences Corp AVXL
• Applied Molecular Transport Inc. AMTI
• Arcus Biosciences Inc RCUS
• argenx SE – ADR ARGX
• Atea Pharmaceuticals Inc AVIR
• BioVie Inc BIVI
• C4 Therapeutics Inc CCCC
• Cassava Sciences Inc SAVA
• Castle Biosciences Inc CSTL
• Cleveland BioLabs, Inc. CBLI
• CorMedix Inc. Common Stock CRMD
• F-Star Therapeutics Inc FSTX
• Frequency Therapeutics Inc FREQ
• Glaukos Corp GKOS
• GW Pharmaceuticals PLC- ADR GWPH (announced a deal to be bought by Jazz Pharmaceuticals PLC JAZZ for $7.2 billion)
• Halozyme Therapeutics, Inc. HALO
• I-Mab ADR IMAB
• Immunome Inc IMNM
• Intra-Cellular Therapies Inc ITCI
• Jounce Therapeutics Inc JNCE
• MannKind Corporation MNKD
• Morphic Holding Inc MORF
• Myriad Genetics, Inc. MYGN
• Nantkwest Inc NK
• Novavax, Inc. NVAX (EU began rolling review of the company's vaccine candidate)
• Oramed Pharmaceuticals, Inc. ORMP
• Organogenesis Holdings Inc ORGO
• Pulse Biosciences Inc PLSE (announced FDA clearance for the CellFX System for dermatologic procedures requiring ablation and resurfacing of the skin)
• Revolution Medicines Inc RVMD
• Selecta Biosciences Inc SELB
• SpringWorks Therapeutics Inc SWTX
• Tyme Technologies Inc TYME (announced additional patents related to its investigational asset for the treatment of COVID-19)
• Veracyte Inc VCYT (announced a deal to buy Decipher Biosciences for $600 million in cash and stock)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 3)

• Opthea OPT

• Stocks In Focus

Novartis, Swiss Partner Announce Positive Data For Antiviral Agents as Therapeutic Option For COVID-19

Novartis AG NVS and Swiss biotech Molecular Partners announced results from a study that assessed SARS-CoV-2 anti-infective molecules, including the collaboration's candidates ensovibep and MP0423, against new viral variants of SARS-CoV-2, showing ensovibep maintained very high potency and activity on all tested viral variants and mutants.

MP0423 maintained activity against all tested viral variants and mutants, but demonstrated a slight loss of potency against the U.K. variant, while remaining in the therapeutic range, the companies added.

"These new data are highly encouraging as we look to initiate our global COVID-19 phase 2/3 registrational study in early Q2 2021 to establish our candidates' emerging profile as potent antiviral agents with the possibility for early therapeutic intervention, said Patrick Amstutz, CEO of Molecular Partners.

Novavax Agrees In Principle to Supply 6M Doses of COVID-19 Vaccine to Swiss Government

Novavax said it has executed a binding Heads of Terms agreement with the government of Switzerland to supply six million doses of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, to the country. Novavax and Switzerland will negotiate a final agreement, with initial delivery of vaccine doses slated to ship following successful clinical development and regulatory review, the company said.

The stock was up 1.15% to $90.37 in after-hours trading.

PolarityTE Issued Notice of Allowance by U.S. Patent Office Related to Methods of Making Skin-regenerative Compositions

Polarityte Inc PTE said the U.S. Patent and Trademark Office has issued a Notice of Allowance for a patent filed on Oct. 19, 2018. The newly allowed claims, the company said, provide additional protection for methods of making skin-regenerative compositions with the company's minimally polarized functional unit technology as well as methods of treatment utilizing the compositions.

Additionally, a decision to grant a patent was recently issued in Malaysia, which allows claims in Malaysia cover the same minimally polarized functional unit compositions as those patented in the U.K.

The stock added 4.45% to $1.29 in after-hours trading.

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

Assertio Announces $5M Settlement Agreement With Insurer

Assertio Holdings Inc ASRT reached a $5 million settlement with its insurance company, resolving a dispute as to whether the opioid lawsuits brought against Assertion, beginning in Mau 2018, were covered under its life sciences liability policies with the insurer.

In after-hours trading, the stock rallied 10.79% to 77 cents.

Karyopharm's Xpovio Gets Approval In Israel For Treating Blood Cancer

Karyopharm Therapeutics Inc KPTI said its Xpovio has been approved by the Israeli drug regulator for the treatment of patients with either multiple myeloma or diffuse large B-cell lymphoma.

The stock was adding 2.57% to $15.14 in premarket trading Thursday.

Earnings

Roche Holdings AG's RHHBY fiscal year 2020 revenues declined 5% 58.32 billion euros ($64.52 billion). Core EPS fell 5% to 19.16 euros. The company expects fiscal year 2021 sales to grow in the low-to-mid single digit range, at constant exchange rates, and core earnings per share to grow broadly in line with sales.

Offerings

Tyme announced definitive agreements with several healthcare-focused institutional and other institutional investors for the sale of an aggregate of 40 million shares of its common stock at a purchase price of $2.50 per share in a registered direct offering priced at-the-market under Nasdaq Rules.

Iterum Therapeutics PLC ITRM said, due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 34.783 million ordinary shares (or pre-funded warrants in lieu thereof) at a public offering price of $1.15 per share. All of the shares (or pre-funded warrants) are being offered by the company.

The stock fell 9.40% to $1.35 in after-hours trading.

Kaleido Biosciences Inc KLDO said it intends to sell, subject to market and other conditions, $50 million of shares of its common stock in an underwritten public offering. All of the shares in the proposed offering are to be sold by Kaleido.

The stock moved down 6.22% to $12.51 in after-hours trading.

Veracyte said it has commenced an underwritten public offering of $400 million in shares of its common stock. All of the shares are being offered by Veracyte.

In after-hours trading, the stock slipped 1.60% to $72.61.

Rhythm Pharmaceuticals Inc RYTM announced a proposed public offering of $150 million of shares of its common stock. All shares in the offering will be offered by the company.

The stock slid 0.64% to $31.24 in after-hours trading.

DURECT Corporation DRRX said it is commencing an underwritten public offering of its common stock. All of the shares to be sold in the offering will be sold by the company, subject to customary closing conditions.

In after-hours trading, the stock plunged 11.85% to $2.53.

On The Radar

Clinical Readouts

Citius Pharmaceuticals Inc CTXR is scheduled to present at the upcoming Virtual Investor Conferences Small and Microcap Showcase, an update on its lead product candidate MinoLok, currently in Phase 3 trials for catheter-related bloodstream infection, and an overview of three other active programs. The presentation is due at 1 pm.

Earnings:

Alexion Pharmaceuticals, Inc. ALXN (before the market open)
Merck & Co., Inc. MRK (Q4 sales up 5% to $12.5 billion and non-GAAP EPS came in at $1.32 Vs Street estimate of $1.38 per share in non-GAAP EPS and $12.68 billion in revenues; The company expects 2021 sales of $51.8 billion to $53.8 billion and non-GAAP EPS of $6.48-$6.68 Vs consensus of $6.41 and $51.77 billion)
Baxter International Inc BAX (before the market open)
Bristol-Myers Squibb Co BMY
Brainstorm Cell Therapeutics Inc BCLI (before the market open)
Quest Diagnostics Inc DGX (before the market open)
Twist Bioscience Corp TWST (after the market close)
Neurocrine Biosciences, Inc. NBIX (after the market close)
Misonix Inc MSON (after the market close)
Gilead Sciences, Inc. GILD (after the market close)
Arrowhead Pharmaceuticals Inc ARWR (after the market close)

IPOs

Blacksburg, Virginia-based Landos Biopharma priced its 6.25-million initial public offering, at $16, at the midpoint of the estimated range of $15-$17. The clinical-stage biopharma focused on the discovery and development of oral therapeutics for patients with autoimmune diseases said it expects the shares to begin trading on the Nasdaq under the ticker symbol LABP.

Sensei Biotherapeutics, Inc., a clinical-stage oncology-focused immunotherapy company, priced its upsized initial public offering of 7 million shares of common stock at a public offering price of $19 per share, for generating gross proceeds of about $133 million. The shares will begin trading on the Nasdaq under the ticker symbol SNSE.

Sana Biotechnology, Inc., which is developing in vivo and ex vivo cell engineering platforms for developing treatments for oncology, diabetes, central nervous system disorders, cardiovascular diseases, and genetic disorders, among others, priced its upsized offering of 23.5 million shares at $25 apiece, above the estimated price range of $20-$23. The shares of the Seattle, Washington-based company will begin trading on the Nasdaq under the ticker symbol SANA.