All-time record high runs continue for the S&P 500, Nasdaq and soon to be bitcoin as momentum continues to be a driving factor of performance.
Biotech continues to show signs of life as the RSI for the group went from 25 to 75 in less than four months, taking less than half the time as the last such move from the pandemic lockdowns.
February 2024 set a new monthly record for biotech equity issuance with nearly $8 billion of paper, bringing the YTD total to nearly $14 billion. Pharma drug sales were +3% in 2023 and are forecasted to grow 7% compounded through 2028 setting the backdrop sustained demand for new innovations. Some market strategists are calling for some broad market consolidation while the bull camp remains comfortable Goldilocks is here to stay.
M&A:
Bayer (BAYN GR) is paying BridgeBio (BBIO) $310 million upfront for an exclusive license in Europe for acoramidis, the biotech’s treatment for transthyretin amyloid cardiomyopathy. Bayer will leverage its existing commercial infrastructure and BridgeBio will also receive sales milestones and royalties starting at the low 30 percentage range
Fibrogen (FGEN) regained all rights for Roxadustat from AstraZeneca (AZN)
Novo-Nordisk (NVO) announced a deal with Neomorph (private) to develop molecular glue degraders for cardiometabolic and rare disease targets. The upfront was not disclosed, but total deal value could reach up to $1.46B
Regulatory:
Inari Medical (NARI) disclosed a DOJ investigation into physician promotion practices
Unitedhealth Group (UNH) disclosed the DOJ has initiated an antitrust probe into UNH
Nuvalent (NUVL) FDA has granted BTD to NVL-520 for the treatment of patients with ROS1-positive mNSCLC who have been previously treated with two or more ROS1 TKIs
Minerva (NERV) received a complete response letter (CRL) from FDA citing insufficient evidence of effectiveness for roluperidone in schizophrenia, lack of concomitant antipsychotic administration data, and inadequate number of subjects for the safety database
Clinical:
Microcap Vivani Medical (VANI) ripped >250% after reporting reported progress with a preclinical program for obesity
Microcap Palatin Technologies (PTN) fell 40% on announcing their pivotal phase 3 trial in dry eye disease failed to achieve key endpoints
Ironwood Pharmaceuticals (IRWD) fell nearly 40% after reporting the pivotal Phase 3 STARS trial evaluating once-weekly subcutaneous apraglutide had a lower magnitude of benefit compared to key competitors on the primary endpoint of PS reduction and several key secondary endpoints missed
Viking Therapeutics (VKTX) rallied over 100% on announcing positive topline results from the Phase 2 VENTURE trial of VK2735, a once weekly injectable dual GLP-1/GIP receptor agonist. The trial showed statistically significant reductions in body weight at all doses compared to placebo with up to 13.1% placebo-adjusted mean weight loss (14.7% from baseline) observed after 13 weeks of treatment. Analysts pointed out this early data compared favorable to market leader Eli Lilly's Zepbound. VKTX plans to meet with FDA to discuss mid-stage trials with hopes to reach the market by 2029-2030. The company completed a spot secondary of 6.47M shares priced at $85/share
Janux Therapeutics (JANX) rallied >200% and remarkably traded near the acquisition price of Ambrx Biopharma (AMAM) on announcing early data from the P1a trial of JANX007 in mCRPC. The company noted at a starting step dose of ≥ 0.2 mg, 6 of 6 (100%) subjects achieved PSA30 declines and 5 of 6 (83%) subjects achieved PSA50 declines. Initial step doses of JANX007 ≥ 0.2 mg drove deeper and more durable PSA responses, including one subject that achieved a PSA90 decline. Cytokine Release Syndrome was observed to be temporary and mild, presenting only as low-grade 1 or 2 events, and was quickly managed with treatment. The company raised ~$300 million at $46.50 and has since fallen >10% below deal price
Capital Markets:
Applied Therapeutics (APLT) raised $100 million from existing insiders at $7.00 per share, representing a premium to the prior close on news FDA accepts govorestat for priority review in classic galactosemia (8/24 PDUFA)
Avidity Biosciences (RNA) traded up on an oversubscribed $400M private placement and plan to share preliminary data in approximately half of the study participants in the Phase 1/2 FORTITUDE trial of AOC 1020 in FSHD in 2Q24
Denali therapeutics (DNLI) raised $500 million in a PIPE transaction priced at $17.06 that extends cash runway into 2028. Shares rallied 38% on the deal from near the 52 week low
Corporate Updates & Earnings:
Inari Medical (NARI) reported a Q4 EPS and Revenue beat and FY24 guides revenues from $580M to $595M vs $588.3M street
Mirum Pharmaceuticals (MIRM) reported a revenue beat and guides FY global net product sales of $310M to $320M
Jazz Pharmaceuticals (JAZZ) reported a Q4 EPS miss and revenue in-line with FY24 guides EPS to $18.15-$19.35 vs $19.94 street and revenues $4.0-$4.2B vs $4.08B street
DocGo Inc (DCGO) reported a Q4 revenue and adj. EBITDA beat and raised 2024 revenue guidance to $720-750M vs prior guidance to exceed $700M
Argenx SE (ARGX) reported a Q4 revenue beat
Acadia Pharmaceuticals (ACAD) reported a Q4 revenue beat and guided FY24 DAYBUE net product sales in the range of $370-420M and NUPLAZID net product sales in the range of $560-590M
Revance (RVNC) reported 4Q ahead at $69.8 million vs $62 million street. Guided 2024 revenue at least $280 million and expenses below 2023 levels. RVNC projects current cash will fund the company through cashflow breakeven
Amicus Therapeutics (FOLD) reported in line 4Q revenue with an EPS beat. 2023 total revenue increased by 21% year on year and 2024 Galafold guide cane is at 11-16%. No guidance was provided for the Pombiliti + Opfolda launch
Krystal Biotech (KRYS) traded up 43% on their earnings beat
Novavax (NVAX) missed on FY24 revenue guide ($800M-$1B v $969.7M street), following 4Q revenue miss
Culling the Herd:
NGM Biopharmaceuticals (NGM) entered into a go-private deal with affiliates of The Column Group for near the cash value of ~$155 million
Gristone Bio (GRST) to cut 40% of workforce