WESTON (dpa-AFX) - This week's biotech landscape saw regulatory approvals across the U.S., Canada, and China, alongside collaborations, acquisitions, program halts, and positive data readouts spanning multiple therapeutic areas, including severely calcified coronary artery disease, Wilson disease, and alpha-1 antitrypsin deficiency.
Let's unpack the specifics.
FDA Approvals and Rejections
HUTCHMED, Innovent Win NMPA Approval for ELUNATE-TYVYT Combo in Advanced Kidney Cancer
HUTCHMED (HCM) and Innovent Biologics, Inc (HKEX:1801) received NMPA approval in China for the combination of ELUNATE (fruquintinib) and TYVYT (sintilimab injection) to treat patients with locally advanced or metastatic renal cell carcinoma (RCC) who previously failed VEGFR-TKI therapy and have not received PD-1/ PD-L1 inhibitors in the first-line setting.
The approval is supported by results of the Phase 3 FRUSICA-2 study, which showed a 63% reduction in the risk of disease progression or death compared with standard therapies, with a median progression-free survival of 22.2 months for the combination versus 6.9 months in the control arm.
HCM closed Thursday's trading (May 21, 2026) at $12.04, up 1.09%.
Sunshine Biopharma Receives Canadian Approval for Generic Amoxicillin
Sunshine Biopharma Inc. (SBFM) received Canadian regulatory approval for its generic formulation of Amoxicillin, one of the most widely used antibiotics worldwide. The approval allows the company to introduce the product across Canada as part of its strategy to expand access to affordable, high-quality antibiotics.
Amoxicillin is commonly prescribed for infections such as strep throat, pneumonia, bronchitis, urinary tract infections, skin, and dental infections. Sunshine Biopharma's version will be available in multiple dosage forms and strengths, with shipment expected to begin in August 2026.
SBFM closed Thursday's trading at $0.51, up 40.59%.
Guardant Health Wins FDA Approval for Guardant360 Liquid CDx
Guardant Health (GH) received FDA approval for Guardant360 Liquid CDx, a next-generation blood-based genomic test that integrates both genomic and epigenomic insights. The new version is now the largest FDA-approved liquid biopsy panel, offering a genomic footprint 100 times broader than the previously approved Guardant360 CDx, enabling more comprehensive tumour profiling.
The test is powered by the company's Smart Platform, an AI-enabled multiomic technology now used across Guardant's full product portfolio.
GH closed Thursday's trading at $118.01, up 2.64%.
AstraZeneca Wins FDA Approval for BAXFENDY in Hypertension
AstraZeneca (AZN) received FDA approval for BAXFENDY, a first-in-class aldosterone synthase inhibitor, for use in adults with hypertension who require additional blood-pressure control alongside other antihypertensive medications.
The approval is based on positive results from the BaxHTN Phase III trial. BAXFENDY works by selectively inhibiting aldosterone production, a hormone that raises blood pressure and contributes to heart and kidney complications. AstraZeneca acquired the drug through its 2023 purchase of CinCor Pharma.
AZN closed Thursday's trading at $189.75, up 1.22%.
Deals
InMed Pharma Signs Merger Agreement with Mentari
InMed Pharmaceuticals, Inc. (INM) entered into a definitive merger agreement with privately held Mentari Therapeutics, Inc., a biotechnology company developing therapies for migraine prevention. The merger will combine Mentari's differentiated migraine pipeline with InMed's public market infrastructure. The transaction is expected to close in the second half of 2026, subject to customary closing conditions.
INM closed Thursday's trade at $1.73, up 7.45%.
Regeneron Collaborates With Parabilis Medicines On Antibody-Helicon Conjugates
Regeneron Pharmaceuticals, Inc. (REGN) has entered into a research collaboration with Parabilis Medicines to develop novel Antibody-Helicon Conjugates. The collaboration begins with five initial targets, with the option to expand further.
Under the agreement, Parabilis will receive $125 million from Regeneron, including a $50 million upfront payment, a $75 million equity commitment, and up to approximately $2.2 billion in potential milestone payments.
REGN closed Thursday's trade at $642.59, down 1.10%.
Nexalin Acquires AI Health Platform
Nexalin Technology Inc. (NXL) announced the acquisition of PONM Inc., a digital health platform that supports Nexalin's HALO Clarity program and Nexalin NeuroCare virtual clinic.
The total consideration for the acquisition is $1.3 million, payable over time in Nexalin common stock, with the price tied to market performance.
For Nexalin, the integrated device-plus-software model is central to its planned pivotal trial of HALO Clarity for moderate-to-severe insomnia, with enrolment expected to begin in the second quarter of 2026.
NXL closed Thursday's trial at $0.39, up 19.10%.
Medtronic To Acquire SPR Therapeutics for $650 Million
Medtronic plc (MDT) announced its intent to acquire SPR Therapeutics, Inc. (SPR), a privately held medical technology company, with an upfront cash payment of approximately $650 million for all the outstanding equity in SPR.
The transaction is expected to close within the first half of Medtronic's fiscal year 2027, which officially began on April 25, 2026.
MDT closed Thursday's trading at $78.15.
Clinical Trials - Breakthroughs & Setbacks
Biogen, Denali Halt BIIB112 After Phase 2b Miss
Biogen (BIIB) and Denali Therapeutics' (DNLI) discontinued BIIB112 after the Phase 2b LUMA study in early Parkinson's disease failed to meet primary and secondary endpoints. The LRRK2 inhibitor showed no clinical benefit compared with placebo, although biomarker reductions and safety were consistent with expectations. Denali will continue its Phase 2a BEACON study in patients with LRRK2 variants, with data expected in H1 2027.
BIIB closed Thursday's trading at $189.47, up 0.89%.
Tiziana Advances Foralumab After Positive Phase 2 Multiple Sclerosis Data
Tiziana Life Sciences (TLSA) reported additional positive findings from its Phase 2 study of intranasal Foralumab in non-active secondary progressive multiple sclerosis (na-SPMS). The company said the treatment continued to show improvements in clinical and imaging measures, including sustained reductions in microglial activation, with a favourable safety profile. Tiziana plans to move forward with further development based on these results.
TLSA closed Thursday's trading at $1.46, down 9.32%.
Monopar's ALXN1840 Shows Strong Copper Reduction in Phase 2 Wilson disease
Monopar Therapeutics Inc. (MNPR) reported Phase 2 results for ALXN1840 in Wilson disease following publication of a peer-reviewed manuscript in Hepatology Communications. The open-label study showed a rapid, statistically significant and sustained reduction in daily copper balance, with a cumulative mean decrease of -6.08 mg over 21 days and an approximately 50% increase in faecal copper output-to-intake ratio. ALXN1840 was generally well tolerated with no serious adverse events reported.
MNPR closed Thursday's trading at $62.68, down 3.49%.
Boston Scientific's FRACTURE Trial Meets Safety, Effectiveness Endpoints
Boston Scientific (BSX) reported positive results from the FRACTURE IDE trial evaluating it investigational SEISMIQ 4CE Coronary Intravascular Lithotripsy Catheter for treating patients with severely calcified coronary artery disease. The study met its primary safety and effectiveness endpoints, showing high rates of freedom from major adverse cardiac events at 30 days and strong procedural success. The device is compatible with the same console used for the SEISMIQ IVL Peripheral Catheter, which received FDA clearance in 2025 for calcified peripheral artery disease.
BSX closed Thursday's trading at $57.15, up 0.85%.
Co-Diagnostics Advances Ebola Test Development Amid Ongoing Outbreak
Co-Diagnostics Inc. (CODX) announced progress on its molecular diagnostic test for Ebola virus, developed using its CoPrimer technology platform. The company said the test is designed for rapid, accurate detection to support outbreak monitoring and containment efforts in affected regions. The update includes the company's newly completed Bundibugyo virus (BDBV) assay, designed for fast, decentralised detection and developed in response to rising alerts about the BDBV-driven Ebola outbreak.
As of May 15, 2026, about 346 suspected cases and 88 deaths had been reported in the Democratic Republic of the Congo, along with 2 cases and 1 death in Uganda, according to Statista.
CODX closed Thursday's trading at $3.71, up 55.23%.
Wave Life Sciences Unveils Positive Findings Of WVE-006 From RestorAATion-2 Trial In alpha-1 antitrypsin deficiency
Wave Life Sciences Ltd. (WVE), a clinical-stage biotechnology company, updated new positive data from the ongoing RestorAATion-2 trial evaluating WVE-006, its investigational candidate for the treatment of alpha-1 antitrypsin deficiency (AATD).
In Pi*ZZ, a genetic subtype of AATD, treatment with WVE-006 led to dose-dependent reductions in circulating mutant Z-AAT from baseline following a single dose, reaching 47.3% (200 mg), 49.7% (400 mg), and 59.1% (600 mg). WVE-006 continues to be well tolerated, with a favourable safety profile, according to the firm.
WVE closed Thursday's trade at $6.42, up 3.72%.
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