IDEAYA Biosciences [IDYA] - Last Close: $14.93
A promising announcement is rallying shares of IDEAYA Bio.
On Sunday, the biotech company announced it had observed "encouraging clinical activity" in a phase 2 study of darovasertib and crizotinib in tumor patients.
The company said an ongoing trial in collaboration with Pfizer [PFE] showed the combination therapy produced a confirmed overall response rate of 45%.
IDEAYA says it plans to begin a registration-enabling phase 2/3 clinical trial sometime in Q2.
IDYA is up 22.5% on the upbeat clinical data.
My Take: IDYA shares are trading near a new low, so this catalyst could set it up for a swing higher. Keep an eye on this one.
ANI Pharmaceuticals [ANIP] - Last Close: $39.52
ANI Pharmaceuticals is rallying after an FDA green light.
The pharma firm announced Monday morning that the Food & Drug Administration approved its application for Nitrofurantoin Oral Suspension USP.
ANI Pharma said the drug is a generic version of Furadantin® Oral Suspension 25 mg/5 ml, which has an approximate market value of $55.5 million.
ANIP is up 23.8% in response to the FDA drug approval.
My Take: ANIP is facing resistance at $45 per share. This rally won't put it over the hump, but it could continue to move higher if it can keep racking up FDA approvals for generic drugs.
Aclarion [ACON] - Last Close: $0.7399
Aclarion just announced the results of a groundbreaking trial.
The company published two-year durability data demonstrating improved surgical outcomes for lower back pain surgeries identified by its Nociscan system.
Aclarion's Nociscan helps physicians identify chemically painful lumbar disks that cause chronic low back pain so they can correct them with surgery.
The two-year data showed Nociscan produced a 22% improvement over patients whose treatment strategies didn't align with platform's indication.
The news made ACON a top premarket mover. It's up 93.2% on elevated premarket trading volume.
My Take: This is a big breakthrough for ACON and it could give the company's revenues a major boost. This rally seems overdone, but there could be an opportunity to get in on a pullback.
Tempo Automation Holdings [TMPO] - Last Close: $0.70
Tempo Automation is running hot after a recent filing.
This morning, the company announced the appointment of a new public accounting firm in a Form 8-K filing.
Tempo dropped its former accountant, BDO, in favor of WithnumSmith+Brown PC.
The company also clarified several issues that BDO noted on the company's last annual filing, and BDO agreed with the assertions in a letter to the SEC.
TMPO is one of today's top movers with a 105.7% premarket gain.
My Take: This was a lucrative pop, but I don't see it lasting for very long. TMPO has problems, and I think this rally will dissipate shortly.