The Daily Biotech Pulse: Lily-Rigel Licensing Deal, vTv Starts Early Stage Psoriasis Study, Immunic Data Readout

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. 17)

• Advaxis, Inc. ADXS
• Angion Biomedica Corp ANGN
• Applied Genetic Technologies Corp AGTC
• Applied Molecular Transport Inc. AMTI
• Avanos Medical Inc AVNS
• Bausch Health Companies Inc BHC
• Bioanalytical Systems, Inc. BASI
• Bioatla Inc BCAB
• Celldex Therapeutics, Inc. CLDX
• Chimerix Inc CMRX
• China Biologic Products Holdings Inc CBPO
• China SXT Pharmaceuticals Inc SXTC
• Cleveland BioLabs, Inc. CBLI
• Diffusion Pharmaceuticals Inc DFFN
• Endo International PLC ENDP
• Integra Lifesciences Holdings Corp IART
• Krystal Biotech Inc KRYS
• Laboratory Corp. of America Holdings LH
• Lucira Health Inc LHDX
• Nektar Therapeutics NKTR (announced a $150-million investment by SFJ Pharma for the Phase 2/3 registrational clinical study of BEMPEG plus Keytruda in patients with head and neck cancer)
• Oncolytics Biotech, Inc. ONCY (reacted to initiation of coverage by H.C. Wainwright with a Buy rating)
• Onconova Therapeutics Inc ONTX
• Oncternal Therapeutics Inc ONCT
• Oramed Pharmaceuticals, Inc. ORMP
• PAVmed Inc PAVM
• Processa Pharmaceuticals Inc PCSA (announced $10.2 million in strategic financing)
• Regulus Therapeutics Inc RGLS
• Silence Therapeutics ADR Representing 3 Ord Shs SLN (announced commencement of Phase 1 study of SLN360 for the treatment of elevated lipoprotein)
• United Therapeutics Corporation UTHR
• Varian Medical Systems, Inc. VAR

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 17)

• Evaxion Biotech A/S – ADR EVAX
• Longeveron Inc LGVN (went public Friday)
• Talis Biomedical Corp TLIS (went public Friday)
• Uniqure NV QURE

Stocks In Focus

Myovant, Pfizer Announce Publication of Positive Late-Stage Data For Combo Therapy To Treat Uterine Fibroids

Myovant Sciences Ltd MYOV and Pfizer Inc. PFE announced the publication in the New England Journal of Medicine of positive results from the Phase 3 LIBERTY 1 and LIBERTY 2 studies of investigational, once-daily relugolix combination therapy in women with uterine fibroids.

The Liberty 1 and Liberty 2 studies achieved 73.4% and 71.2% response rates, respectively, in menstrual blood loss, with an average reduction of 84.3% from baseline.

The studies also achieved six of the seven key secondary endpoints, including reduction of pain. Additionally, bone mineral density was maintained at levels comparable to placebo.

Pfizer and Myovant are collaborating for the development and commercialization of relugolix.

Myovant was up 1.25% premarket at $22.64.

vTv Commences Phase 1 Study Of Psoriasis Drug

vTv Therapeutics Inc VTVT announced the initiation of a Phase 1 multiple ascending dose study evaluating HPP737, an orally administered phosphodiesterase type 4 inhibitor, to assess its pharmacokinetics, pharmacodynamics, safety and tolerability in healthy adult volunteers.

The goal of this study, the company said, is to determine the maximum tolerated dose with minimal or no gastrointestinal intolerance to inform dose selection for a Phase 2 study in psoriasis that is planned for later this year. The company said it expects to complete the study in the second quarter.

The stock was up 0.38% premarket at $125.13. 

Provention Bio Out-Licenses Autoimmune Disorder Drug In Greater China

Provention Bio Inc PRVB and Hangzhou Zhongmei Huadong Pharmaceutical announced a strategic collaboration to develop and commercialize PRV-3279 — a bispecific antibody-based molecule targeting the B cell surface proteins CD32B and CD79B — in Greater China. Provention Bio will retain all rights to PRV-3279 in the rest of the world.

Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus, a chronic autoimmune disorder characterized by an abnormal overactivation of B cells and subsequent pathologic production of auto-antibodies.

The agreement provides for Provention receiving an upfront payment of $6 million, and up to $11.5 million in funding over the next three years to cover costs anticipated to be incurred by Provention Bio in connection with research, development and manufacturing activities.

Provention Bio is eligible to receive additional milestone payments of up to $172 million if certain regulatory and commercial objectives are achieved, as well as low-to-mid double-digit royalties as a percentage of net sales of PRV-3279 by Huadong in Greater China.

The stock was trading 3.38% higher premarket at $15. 

Related Link: The Week Ahead In Biotech: FDA Decision On G1 Therapeutics, Earnings In The Mix For Light Calendar Week

Lily, Rigel To Collaborate On Therapies For Immunological, Neurologic Diseases

Eli Lilly And Co LLY and Rigel Pharmaceuticals, Inc. RIGL announced an exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel's lead candidate R552, a RIPK1 inhibitor, for all indications including autoimmune and inflammatory diseases. Lilly will also lead all clinical development of brain penetrating RIPK1 inhibitors in central nervous system diseases.

Under the terms of the agreement, Lilly will make an upfront cash payment to Rigel of $125 million. Rigel may also be eligible to receive up to $835 million in potential development, regulatory and commercial milestone payments, as well as tiered royalties ranging from the mid-single digit to high-teens that will vary depending upon Rigel's clinical development investment.

Lilly will be responsible for all costs of global commercialization for R552, and Rigel will have the right to co-commercialize R552 in the U.S.

In pre-market trading Thursday, Lily shares were little changed, while Rigel was soaring 25.17% to $5.67.

Immunic's IMU-838 Aces Midstage Chronic Liver Disease Study

Immunic Inc IMUX announced positive top-line data from an investigator-sponsored Phase 2 proof-of-concept clinical trial of IMU-838 in primary sclerosing cholangitis.

The stock was rising 2.96% to $20.89 in premarket trading Thursday.

Seelos Amends Agreement With Licensing Partner To Buy Portion of Future Royalty Payment

Seelos Therapeutics Inc SEEL announced an amendment of the agreement with Vyera Pharmaceuticals AG for the development of SLS-002 to repurchase in cash a significant portion of the royalties payable on any future net sales of SLS-002.

Under this amendment, for additional cash payments, Seelos has agreed to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002.

The stock was adding 4.42% to $4.02 in premarket trading Thursday.

Immunome Identifies Potent Antibodies Effective Against Several SARS-CoV-2 Variants

Immunome Inc IMNM said its discovery engine has isolated potent antibodies capable of neutralizing several SARS-CoV-2 variants, including the South African Variant (B.1.351), in pseudovirus testing.

This effort is part of the company's ongoing program to develop a cocktail of antibodies targeting spike and non-spike proteins that can serve as a prophylaxis or a treatment for COVID-19, the company said.

The stock was rallying 170.03% to $60 premarket Thursday.

Merrimack, Prothena, Corvus Rally On Insider Buying

Merrimack Pharmaceuticals Inc MACK rallied after a filing revealed that Gary Crocker, a director of the board, bought 5,000 shares in the company at a price of $7.4684 per share.

The stock gained 10.16% premarket to $9.11.

Prothena Corporation PLC PRTA shares moved to the upside following filings that revealed a series of insider transactions.

The stock was up 10% premarket at $26.40.

A 13D filing revealed Orbimed Advisors beneficially owns 8.053 million shares of Corvus Pharmaceuticals Inc CRVS, giving it a 21.98% stake. A separate filing also showed that its CEO Richard Miller bought 100,000 shares at $3.50 each.

The stock was up 7.22% premarket at $3.86. 

Earnings

Royalty Pharma plc RPRX (before the market open)

Ironwood Pharmaceuticals, Inc. IRWD (before the market open)

Blueprint Medicines Corp BPMC (before the market open)

10X Genomics Inc TXG (after the close)

Invitae Corp NVTA (after the close)

Globus Medical Inc GMED (after the close)

Shockwave Medical Inc SWAV (after the close)

Veracyte Inc VCYT (after the close)

Viking Therapeutics Inc VKTX (after the close)

Offerings

Veru Inc VERU prices an underwritten public offering of 6.4513 million shares of its common stock at a price to the public of $15.50 per share. The gross proceeds to Veru from the offering are expected at around $100 million. The offering is expected to close on or about Feb. 22.

The stock fell 7.5% premarket to $15.92.

Molecular Templates Inc MTEM said it has commenced an underwritten public offering of its common stock. All of the shares in the offering are to be sold by Molecular.

In premarket trading, the stock plunged 7.12% to $12.65.

On The Radar

Earnings

West Pharmaceutical Services Inc. WST (before the market open)

Syneos Health Inc SYNH (before the market open)

Avanos Medical Inc AVNS (before the market open)

Integra Lifesciences (before the market open)

Emergent Biosolutions Inc EBS (after the close)

Quidel Corporation QDEL (after the close)

Opko Health Inc. OPK (after the close)

Oyster Point Pharma Inc OYST (after the close)

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