Delcath Systems [DCTH] - Last Close: $3.12
A regulatory win is boosting shares of Delcath Systems.
Late Monday, the oncology drug company said the FDA approved its HEPZATO KIT as a "liver-directed treatment for metastatic uveal melanoma."
Regulators approved the treatment after data from a Phase 3 trial showed the drug produced satisfactory responses in patients.
Delcath said it expected the product to be commercially available by Q4 2023.
DCTH is this morning top stock with a 66.7% gain on elevated trading volume.
My Take: DCTH has been locked in a steep downtrend since the start of June, but this news could help share prices rebound towards its previous highs.
Arena Group [AREN] - Last Close: $3.38
Arena Group just announced a new deal.
After Monday's close, the media company announced the signing of a new letter of intent to combine with certain asses of Simplify Inventions' Bridge Media Unit.
Under the terms of the deal, Arena will get a $50 million cash investment from Simplify, plus a $60 million advertising commitment over five years.
In return, Simplify will get $25 million of preferred stock at a 10% non-cash coupon with a 5-year term and 65% ownership of the newly combined company.
The companies expect to close the deal before the end of the year. AREN is up 18.3% in response to the news.
My Take: Not exactly a massive rally for AREN, but this could be a promising development. This stock has struggled in recent months, so it'll be interesting if this deal helps it recover.
Tiziana Life Sciences [TLSA] - Last Close: $0.6023
Tiziana Life Sciences is breaking out after a favorable regulatory decision.
Minutes ago, the biotech company said the FDA cleared its investigational new drug application for intranasal foralumab for Alzheimer's patients.
Tiziana acting CEO Gabriele Cerrone called the decision a "significant milestone" that highlights the drug's "strength and therapeutic potential."
Phase 2 trials for the drug are expected to kick off some time in Q3.
News of the FDA green light catapulted TLSA to a 56.9% premarket gain.
My Take: An effective Alzheimer's treatment is the biotech industry's Holy Grail, so it's no surprise we're seeing a big reaction out of TLSA. However, only time will tell if the drug lives up to the hype.
SCYNEXIS [SCYX] - Last Close: $2.80
A strong quarterly report is boosting shares of SCYNEXIS today.
Late Monday, the pharma firm released its Q2 earnings report, and the results exceed analysts' expectations.
SCYNEXIS reported Q2 EPS of $2.46 on sales of $131.5 million. Consensus estimates called for $1.55 EPS on $95.45 million in revenues.
The company's Q2 results beat the Street's estimates by a wide margin, and shares immediately took off after the earnings data hit the market.
SCYX is up 24.4% in today's premarket.
My Take: SCYX has been trapped in a narrow trading range for the past few months. Today's rally could help it break out.
