We'll see - this is ripe for a massive squeeze.
I don't think it takes a beating if he says 'by end of year' - he always said that they will not narrow down the estimated timeframe for submission. It will only take a beating if he insinuates that there is some wiggle room going beyond this year for submission. I still think they file within the next 4-6 weeks.
Roth Capital affirms its Buy rating and $8 price target on Galena Biopharma (Nasdaq: GALE) after the company announced the product launch for Zuplenz (ondansetron) Oral Soluble Film in the United States.
Analyst Richard Pantginis commented, We expect a modest contribution to revenue from Zuplenz upon launch. We base this from tracking previous Zuplenz sales and we expect the launch to be followed by gradual uptake supported by strong marketing efforts on GALE's part.
Recall that the company stated it will not use the voucher program which accompanied Abstral's launch but instead will use a co-pay assistance program and physicians samples. From tracking Abstral sales, we continue to see volatility, which is reflected in Galena's quarterly reports. We reiterate our investment thesis stating that investors should focus on pipeline clinical developments and view Abstral and Zuplenz revenue as cash flow to support ongoing R&D efforts to advance GALE's clinical assets. Our valuation puts the biggest emphasis on GALE's clinical stage assets, particularly NeuVax.
Non issue - here's the part you left out:
The offence is extremely minor. According to a New York traffic attorney:
Aggravated unlicensed operation is when a motorist was previously issued a NY license or otherwise had privileges to drive in New York State and then something happened whereby their license or privilege to operate a motor vehicle was suspended or revoked. Notwithstanding the NY suspension or revocation, the motorists continued to drive. The charge, New York Vehicle and Traffic Law VTL § 511, AUO, is a criminal misdemeanor. This is distinct from unlicensed operation where the person just does not have a license. That charge would be the non-criminal infraction of unlicensed operation, NY VTL § 509. While unlicensed operation it is a big problem for the insurance implications, it is not a criminal case.
AUO 3rd Degree: NY VTL § 511(1)(a): A misdemeanor which carries a fine and surcharge of over $500.00, jail of up to 30 days, and probation.
The Saratoga Police Department did not immediately respond to a request for comment.
UPDATE: Baupost told ValueWalk that the original "offense" was related to a dated traffic violation (specifically, a speeding ticket that had been paid) and the police had incorrect address information. All of the issues have now been resolved.
Maybe this pops like ITEK with a significant reveal during AD - but the lack of any runup so far says otherwise. Long and strong - but this is now a 'show me' situation. This will either be under $3 or above $10 after AD - nothing in between.
This is from the Curetoday website. Here are the excerpts relevant to Neuvax:
What if the standard of care works but the risk for recurrence is high? Vaccines may, in fact, help lessen the risk that the disease will return. One vaccine being developed to prevent recurrence is NeuVax (nelipepimut-S), which is now in phase 3 testing in survivors of early-stage, node-positive breast cancer with low to intermediate expression of HER2, previously treated with chemotherapy, radiation and hormone therapy. NeuVax consists of a small piece of the HER2 protein attached to GM-CSF. Like other vaccines, it causes only mild side effects such as pain or itching at the injection site.
The combination that makes up NeuVax “is like a spark plug to get the immune response going,” says investigator Elizabeth Mittendorf, associate professor in the department of surgical oncology at the University of Texas MD Anderson Cancer Center. In earlier trials, only 5.6 percent of patients on NeuVax suffered recurrences, while more than 20 percent of control patients — those who weren’t on the vaccine — saw their cancers return. “It’s very exciting; the vaccine stimulates an immune response that’s potentially lifelong,” Mittendorf says.
That’s a comforting prospect for Diane Altenburg, a participant in the phase 3 NeuVax study. Altenburg survived cancer in one breast 15 years ago, only to see it recur four years later on the other side; she had lumpectomies on both sides. During the NeuVax trial, she received an injection of the vaccine once a month for six months, followed by booster shots every six months for three years. Today she is cancer-free, off all medications and required only to have mammograms every six months. While it is possible that she could have remained disease-free with only standard therapy, this study will assess enough patients to demonstrate whether or not the vaccine can actually improve the cure rate.
BIIB is in a bad place right now - we might see a bidding war - who knows.
Almost never happens with biotech companies at this stage - but I think even a token $10-15M buyback program would show that management has the confidence that they can deliver.
Hard to call a bottom - if it drops to $250-260 I'll add more. $275 buy-in average is not bad looking out 12-18 months.
$300 is my buy point. I think BIIB buys ACAD within 3-6 months - sending this back to $400.
You're assuming that he has the same confidence in the sales team now as he did when the stock was trading at 8. Don't think that's the case.
True - but they could have easily set the bonus date as December 31 to align with the company's stated goal of submitting the NDA by the end of the year. Worse thing that could happen is Davis leaving on September 22nd after collecting his bonus without the NDA having been submitted - that would be extremely damaging to the pps - and I think (hope) that the board took that into account.
He didn't build a 20% stake to watch this tank to 2 year lows. By any reasonable metric - the launch and uptake of the drug have been abysmal. Yes - more coverage will take effect within the next 2-3 months - but even a spike in weekly scripts to the 500-600 range is still not good enough.
Madison owns this. The only reason he was hired was to ensure that Auryxia becomes a success story. He had more than enough time to set up pre- and post-launch marketing activities and to build up a solid sales team. They raised over $100M in a secondary early this year - so there was plenty of $$ for advertising, etc.
At this rate - the pps will undoubtedly trend down to the $5-6 level - unless a significant change is made in getting the drug to market. If this sales team can't deliver - then don't go at it alone anymore.
Seth has a few options as I see it - and I can't see him waiting more than 3-6 months at most to take action:
1. Sit idly by and watch the pps further deteriorate (not going to happen)
2. Push Madison out (not likely - but you never know)
3. Take a more activist role like Jana did recently with QCOM (may happen, but I don't think that's his style)
4. Completely liquidate his stake (reasonable possibility - and the rest of us won't find out until it's too late)
5. Actively seek out a buyer for the company (reasonable possibility - but the buyout price now will undoubtedly be less than it was a year ago)
I may be wrong with all these assumptions - but one way or another the future of this company will be defined within the next 6 months. I'm staying long for now - but Madison better bring it during the next CC. If I don't see a sense of urgency and a realization that what has happened to date is not acceptable - I'm out.
New article out today in The Pharmaceutical Journal - can't post it all here - so google it.
Neuvax is mentioned in a couple of excerpts:
“The checkpoint inhibitors brought immunotherapy to the forefront of cancer therapy,” says Jay Berzofsky, an immunologist at the US National Cancer Institute (NCI) in Bethesda, Maryland. And Mark Schwartz, chief executive of Galena Biopharma, a Portland, Oregon-based company focusing on oncology, agrees. “The checkpoint inhibitors have validated the basic concept that unleashing T cells against cancer can be very effective,” he says.
Although the immune response elicited by cancer vaccine monotherapy so far may not be sufficient to eliminate bulky, metastatic disease, it might more effectively eliminate tiny, undetectable micrometastases to reduce the rate of disease recurrence following surgical removal of a localised tumour.
In the adjuvant setting, cancer vaccines could lead to an antigen-specific memory T-cell response that lasts for an extended period of time, potentially a lifetime. And the cancer may also be less likely to develop resistance than with traditional therapy, as long as the vaccine can generate a broad-based immune response.
“The setting is one of the most critical components of making a vaccine work,” says Galena’s Schwartz. The company is testing its vaccine, NeuVax (nelipepimut-S), which includes a peptide antigen derived from the HER2 protein, in the adjuvant setting in a phase III trial in breast cancer.