RegeneRx (RGN) Falls On Stock Offering
RegeneRX (RGN) is off 24% to $.85 on news that it has entered into a securities purchase agreement with new institutional investors for the sale of 4,512,195 shares of its common stock in a registered direct offering at $0.82 per share. In addition, warrants to purchase 2,256,098 shares of common stock will be issued to the investors. The warrants are immediately exercisable, have a term of 5 years and an exercise price of $1.12 per share. Gross proceeds of the offering, before deducting placement agent fees and other estimated offering expenses payable by RegeneRx, are expected to be approximately $3.7 million
Douglas A. McIntyre
Discovery Laboratories (DSCO) Soars 45% On FDA News
Discovery Labs (DSCO) held a teleconference on September 29, 2009 with the U.S. Food and Drug Administration (FDA). The meeting established an approach to potentially resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin(R) (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants. The meeting focused on Discovery Labs’ plans regarding optimization and final method validation of its fetal rabbit Biological Activity Test (BAT, a quality control and stability release test) and a proposed limited Surfaxin clinical trial design, which would simultaneously employ the newly-optimized BAT.
At the meeting, the FDA indicated that Discovery Labs’ proposed program to optimize and validate the BAT is reasonable. The program is intended, among other things, to confirm that the BAT can adequately distinguish change in Surfaxin biological activity over time. As a result of the meeting, Discovery Labs believes that it has reached an understanding with the FDA and is confident that it will be able to optimize the BAT to the satisfaction of the FDA. Discovery Labs intends to employ the optimized BAT in conjunction with all of Discovery Labs’ KL4 surfactant pipeline programs, including the potential limited Surfaxin clinical trial.
In addition, Discovery Labs received guidance from the FDA on its proposed limited clinical trial design. The trial design is intended to primarily assess a pharmacodynamic (PD) response following Surfaxin administration in preterm infants with RDS. This design was selected to address FDA requirements for Surfaxin approval while limiting trial expense and duration. The FDA indicated that a PD-based approach is consistent with their expectation for a limited clinical trial and also provided direction regarding trial design specifics. The final clinical trial design will be subject to FDA review following submission of a formal protocol. Discovery Labs expects to finalize a protocol and anticipates submitting it to the FDA in mid-fourth quarter of 2009.
The shares are up 45% to $1.11
Douglas A. McIntyre
Marshall Edwards (MSHL) Up 130% On New Data
Marshall Edwards (MSHL) released data demonstrating that the efficacy of NV-128 in animal xenograft models is achieved without apparent toxicity.
NV-128 is a novel flavonoid small molecule mTOR inhibitor, capable of inhibiting both mTORC1 and mTORC2 pathways which are central to the aberrant proliferative capacity of both mature cancer cells and cancer stem cells.
The data demonstrated that NV-128 has much greater safety than some other mTOR inhibitors in mice bearing human ovarian cancer xenografts.
Most of the current compounds acting on this pathway are analogs of rapamycin, known as rapalogs. Rapamycin and its analogs are regarded as the archetypal inhibitors of mammalian target of rapamycin or mTOR. In addition to their reported toxicities, rapalogs have been shown to contribute to the development of drug resistant tumors and ultimately reduced effectiveness over time due to their inability to efficiently inhibit mTORC2, a complex of mTOR with “rictor” (rapamycin-insensitive companion of mTOR).
NV-128 administered daily resulted in a reduction in tumor volume of 51 per cent relative to untreated control animals after 15 days, compared to a 50 per cent reduction in mice given rapamycin every other day. However, whereas rapamycin treated mice lost 8 per cent of body weight over this period, NV-128 treated mice gained weight, finishing at 6 per cent above their starting weight after the 15 day period. This is a significant indicator of lack of toxicity for NV-128, whereas the weight loss in the rapamycin-treated mice was judged to be a reflection of the well documented toxicity of rapamycin in both animal and human studies. After 21 days the tumors were removed and weighed. In NV-128 treated mice, tumor mass was reduced by 41 per cent compared to vehicle controls, an effect equivalent to rapamycin treated animals in which tumor mass was reduced by 44 per cent.
Douglas A. McIntyre
Repros Therapeutics (RPRX) Slaughtered On Trial Results
Shares in Repros Therapeutics (RPRX) are off 15% to $.92 on news that the FDA may ask for more data on its lead drug Proellex.
Douglas A. McIntyre
Sequenom (SQNM) Stock Crushed On Disclosures
SEQUENOM (SQNM) is off 45% to $3.18 on news that the company’s board of directors have concluded that as a result of the company’s attempted transition from researching potential molecular diagnostic tests to developing and commercializing those tests, the company failed to put in place adequate protocols and controls for the conduct of studies in the Trisomy 21 program at the company. Certain of the company’s employees also failed to provide adequate supervision. In the absence of such protocols, controls and supervision, the test data and results in the company’s Trisomy 21 program included inadequately substantiated claims, inconsistencies and errors. Due to deficiencies in the company’s disclosure controls and procedures, in a number of instances such test data and results were reported to the public in the company’s press releases and other public statements.
The company has terminated the employment of its president and chief executive officer, Harry Stylli, Ph.D., and its senior vice president of research and development, Elizabeth Dragon, Ph.D., effective immediately.
Douglas A. McIntyre
Market Shrugs Off Big Allos Therapeutics (ALTH) News
Shares of Allos Therapeutics (ALTH) are going nowhere fast on eight million shares traded.
The company said the U.S. Food and Drug Administration (FDA) granted accelerated approval for FOLOTYNTM (pralatrexate injection) for use as a single agent for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment option for patients with relapsed or refractory PTCL. This indication is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. Allos expects to make FOLOTYN available to patients in the U.S. in October.
The stock is up only 2.8% to $8.37.
Douglas A. McIntyre
Helicos BioSciences (HLCS) Soars, But Will Probably Sell Off
Helicos BioSciences (HLCS) is up 32% to $3.20 very near its 52-week high. The period low is $.21 so consider the shares over-bought and ripe for a sell-off, particularly because today’s news is not spectacular.
The firm announced the publication of a landmark study in which Helicos’ True Single Molecule Sequencing (tSMS)™ technology was used to directly sequence individual molecules of RNA. The paper appeared yesterday in the on-line edition of Nature and will appear in an upcoming 2009 print issue of Nature.
The study consists of the accurate sequencing and quantitation of RNA molecules obtained directly from a biological sample without amplification, ligation or cDNA synthesis.
Any revenue potential from that?
Douglas A. McIntrye
Chelsea Therapeutics (CHTP) Slides 73% On Huge Volume
Chelsea Therapeutics (CHTP) is off 73% to $1.85, near its 52-week low. The period high is $7.51.
The firm said top-line results from Study 302, the first of two Phase III trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA) during the double-blind phase of trial, the study’s primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported.
In other words, the trial was a failure.
Douglas A. McIntyre
Warner Chilcott Looking Craftier in Deal Making (WCRX, PG)
Warner Chilcott plc (NASDAQ: WCRX) may have figured an even cheaper way of acquiring the pharma business from Procter & Gamble (NYSE: PG). The company is effectively selling its licensing rights of its topical psoriasis treatments to Leo Pharma, who is reacquiring the licensing rights from Warner Chilcott for about $1 billion. The deal will result in a one-time gain of roughly $450 million and will net Warner Chilcott roughly $980 million in cash.
Leo will also regain the rights to Taclonex, Taclonex Scalp, Dovonex and all products in the developer’s pipeline. Warner Chilcott will continue marketing these drugs for Leo, through the end of the year. Warner Chilcott is to also further assist with the transition for up to a year. The companies have been partners since 2003.
Warner Chilcott will use the funds to pa down its senior secured facilities and also to help finance the acquisition of Proctor & Gamble’s pharma division.
As long as the figures come to pass as we have been told through 2010 by Warner Chilcott and P&G, then it seems as though Warner Chilcott has figured out how to be rather crafty in its strategy.
Shares are up over 1% at $19.99 today and the 52-week trading range is $9.24 to $22.94.
JON C. OGG
Opexa Therapeutics (OPAX) Up 25% On Milestone
Opexa Therapeutics (OPAX) is up 25% to $4.31, still below its 52-week high is $6.93
The firm said it has achieved its first technology transfer milestone in connection with the company’s recently announced exclusive stem cell agreement with Novartis, one of the world’s largest healthcare companies. The milestone was completed on schedule and triggers a payment of $500,000 to Opexa
Opexa recently announced that it entered into an exclusive agreement with Novartis for the further development of Opexa’s novel stem cell technology. Under the terms of the agreement, Opexa received an upfront cash payment of $3 million and was entitled to an additional $1 million as a technology transfer fee to be paid over the course of a six month period. The $500,000 milestone is part of this $1 million technology transfer fee. Total payments to Opexa, including the upfront payment, the technology transfer fee and development and commercial milestone payments could exceed $50 million not including royalties. Opexa is also eligible to receive royalty payments from the sale of any products resulting from the use of the technology and retains an option on certain manufacturing rights
Douglas A. McIntyre
