The Daily Biotech Pulse: Bristol Myers, BridgeBio Ink Oncology Pact, FDA Nod For Lava Therapeutics Blood Cancer Study And More

Zinger Key Points
  • The FDA has signed off LAVA Therapeutics' investigational new drug application for LAVA-051, its lead product candidate for relapsed or refractory chronic lymphocytic leukemia, multiple myeloma and acute myeloid leukemia.
  • The FDA has granted an orphan drug tag to Stealth BioTherapeutics Corp's elamipretide for Duchenne muscular dystrophy. 

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

Stocks In Focus

BridgeBio Inks Licensing Pact With Bristol Myers For SHP2 Inhibitor In Oncology

BridgeBio Pharma Inc BBIO has announced an exclusive license with Bristol Myers Squibb Co BMY to develop and commercialize BBP-398 in oncology. 

BridgeBio will receive an upfront payment of $90 million, up to $815 million in milestone payments and tiered royalties in the low- to mid-teens. 

BridgeBio will retain the option to acquire higher royalties in the U.S. in connection with funding a portion of development costs upon the initiation of registrational studies.

BBIO shares are up 6.53% at $5.55 during the premarket session on the last check Thursday.

FDA Green Lights Lava Therapeutics' Blood Cancer Trial

The FDA has signed off LAVA Therapeutics N.V's LVTX investigational new drug (IND) application for LAVA-051, its lead product candidate for relapsed or refractory chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML).

The Phase 1/2a trial currently includes patients with relapsed or refractory CLL and MM. AML patients will be included later in the study. 

Shares are rising 4.38% at $3.81 during the premarket session.

Stealth BioTherapeutics' Elamipretide Receives Orphan Drug Tag For Duchenne Muscular Dystrophy

The FDA has granted an orphan drug tag to Stealth BioTherapeutics Corp's MITO elamipretide for Duchenne muscular dystrophy. 

FDA's Division of Neurology I has granted the company's request for a pre-IND meeting to discuss a development path for elamipretide in combination with products within the approved therapeutic class of exon-skipping phosphorodiamidate morpholino oligomers.

Shares are up 47.3% at 28 cents during the premarket session. 

Acorda Therapeutics Inks Distribution Pact For Parkinson's Drug In Latin America

Acorda Therapeutics Inc ACOR and Biopas Laboratories have entered into distribution and supply agreements to commercialize Inbrija in Latin America. 

Inbrija is indicated in the U.S. for the intermittent treatment of episodic motor fluctuations in adult patients with Parkinson's disease treated with a levodopa/dopa-decarboxylase inhibitor.

Under the terms of the agreements, Acorda will receive a double-digit, tiered percentage of the selling price of Inbrija in Latin America in exchange for the supply of the product. 

Acorda will also receive sales-based milestones.

Salarius Shares Surge After Pre-IND Meeting For Its Cancer Candidate 

Salarius Pharmaceuticals Inc SLRX has completed its pre-IND meeting process with the FDA for SP-3164, a targeted protein degrader inducing selective elimination of cancer-causing proteins. 

Salarius is developing SP-3164 as a potential treatment for hematological cancers and solid tumors.

Salarius said it obtained valuable FDA input through the pre-IND meeting process that clarified preclinical, clinical, and other regulatory matters for preparing and submitting an IND. 

Salarius plans to submit an IND in 2023 and initiate the first clinical trial.

Shares are surging 56.3% at 25 cents during the premarket session.

Related: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

Lannett, Areva Pharma Ink US Distribution Pact For Leukemia Med

Lannett Company Inc LCI entered into an agreement with Areva Pharmaceuticals to be the exclusive the U.S. distributor of fludarabine phosphate for Injection, USP, 50 mg/2mL, single-dose vials.

Fludarabine phosphate injection is indicated for B-cell chronic lymphocytic leukemia patients who have not responded to or whose disease has progressed during treatment.

The product generated annual sales of $4.9 million. According to IQVIA, the current market value is believed to be higher due to the recent market disruptions.

Under the agreement, Lannett will receive a share of the profits. Other financial terms were not disclosed.

MediWound Posts Promising EscharEx Data For Chronic Wounds

MediWound Ltd MDWD has announced results from its U.S. Phase 2 clinical study of EscharEx for the debridement of venous leg ulcers. 

The study met its primary and secondary endpoints and wound closure safety measurements. 

The study demonstrated that patients treated with EscharEx had a statistically significant higher incidence of complete debridement during the 14-day measurement period within up to eight applications than gel vehicle (EscharEx: 63%) vs. gel vehicle: 30%. 

Shares are up 10% at $1.98 during the premarket session.

MoonLake Immunotherapeutics Kickstarts Phase 2 Trial Of Nanobody Sonelokimab In Chronic Skin Disorder

MoonLake Immunotherapeutics AG MLTX has randomized and dosed the first patient in its Phase 2 trial of sonelokimab for moderate-to-severe hidradenitis suppurativa, a chronic skin condition.

The MIRA trial will evaluate the efficacy and safety of different doses of sonelokimab, compared with placebo, with adalimumab as an active control reference arm in over 200 patients.


Intrinsic Medicine Inc INRX has filed with the SEC regarding an initial public offering of 4.12 million shares.

The company expects to price the offering between $5 and $7 per share.


Palatin Technologies Inc PTN will sell 8.1 million shares of its Series B and 900,000 shares of its Series C convertible redeemable preferred stock for gross proceeds of $15 million.

Each share of Series B and Series C preferred stock has a purchase price of $1.67 and is convertible at an initial conversion price of 45 cents per share. 

Shares are slipping 2.79% at 32 cents during premarket trading.

On The Radar

Stock Split

Rockwell Medical Inc RMTI has approved a 1-for-11 reverse split, effective Friday at 12:01 a.m. eastern time.


The earnings list presented is not comprehensive. Click here to access Benzinga's earnings calendar for the complete schedule.

X4 Pharmaceuticals Inc XFOR: Before Market Open.

Dare Bioscience Inc DARE: Before Market Open.

Matinas BioPharma Holdings Inc MTNB: Before Market Open.

Orchard Therapeutics PLC ORTX: Before Market Open.

Altimmune Inc ALT: Before Market Open.

SCYNEXIS Inc SCYX: Before Market Open.

Zealand Pharma A/S ZEAL: Before Market Open.

Veru Inc VERU: Before Market Open.

Brickell Biotech Inc BBI: After Market Close.

Spectrum Pharmaceuticals Inc SPPI: After Market Close.

Regulus Therapeutics Inc RGLS: After Market Close.

Ibio Inc IBIO: After Market Close.

Salarius Pharmaceuticals Inc SLRX: After Market Close.

CymaBay Therapeutics Inc CBAY: After Market Close.

Marinus Pharmaceuticals Inc MRNS: After Market Close.

OpGen Inc OPGN: After Market Close.

Lineage Cell Therapeutics Inc LCTX: After Market Close.

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